Clinical Trial Podcast http://clinicaltrialpodcast.com Expert Insights for Clinical Research Professionals Fri, 12 Jan 2018 19:00:50 +0000 en-US hourly 1 https://wordpress.org/?v=4.8.5 CTP 008: Exceptional Clinical Research Insights with Norman Goldfarb http://clinicaltrialpodcast.com/norman-goldfarb-interview/ http://clinicaltrialpodcast.com/norman-goldfarb-interview/#respond Fri, 12 Jan 2018 19:00:50 +0000 http://clinicaltrialpodcast.com/?p=529 The post CTP 008: Exceptional Clinical Research Insights with Norman Goldfarb appeared first on Clinical Trial Podcast.

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CTP 007: The Future with EMR with Dr. Manfred Stapff http://clinicaltrialpodcast.com/interview-manfred-stapff/ http://clinicaltrialpodcast.com/interview-manfred-stapff/#respond Mon, 01 Jan 2018 19:46:18 +0000 http://clinicaltrialpodcast.com/?p=523 “It is important that you start with the big picture” – Dr. Manfred Stapff This is episode Dr. Manfred Stapff, Chief Medical Officer at TriNetX shares with us the use and application of real-world data in clinical trial. Manfred Stapff is a physician and board-certified clinical pharmacologist with an extensive...

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“It is important that you start with the big picture” – Dr. Manfred Stapff

This is episode Dr. Manfred Stapff, Chief Medical Officer at TriNetX shares with us the use and application of real-world data in clinical trial.

Manfred Stapff is a physician and board-certified clinical pharmacologist with an extensive career in clinical and pharmaceutical medicine. He was formerly an Executive Director at Actavis, Forest Laboratories, and Merck and also served as a Medical Officer in the German Air Force. Manfred earned his MD and Ph.D. from the Ludwig Maximilian University of Munich.

In this interview, Manfred shares his personal story as a general physician for pilots to an industry professional in clinical trials.

Manfred also has exceptional advice for physicians looking to get into clinical research. To wrap up, we talk about his role as a liaison between medical science and clinical operations.  

I hope you enjoy this interview with Dr. Manfred Stapff.

Listen to it on iTunes.
Stream by clicking here.
Download as an MP3 by right-clicking here and choosing “save as.”

Selected Links from the Episode:

  • Connect with Manfred

LinkedIn

Show Notes:

  • About TriNetX [02:15]
  • The changing landscape in protocol design [04:16]
  • How TriNetX is helping scientist and health care organizations [06:57]
  • What types of people are companies like TriNetX hiring [10:54]
  • Transitioning from general physician for pilots to Merck [13:32]
  • Advice for medical school students and graduates interested in clinical research [18:12]
  • Working at CROs – what to expect [23:27]
  • Why patient enrollment is challenging [25:29]
  • Why should sites consider being part of networks such as TriNetX [28:11]
  • How clinical (medical) and industry can be advantageous to you [31:08]
  • Importance of doing the “dirty work” in clinical research [32:46]
  • Importance of doing the “dirty work” in clinical research [32:46]
  • Being open to other people’s opinions [36:30]
  • Dealing with tension between science and clinical operations [28:43]
  • Keeping yourself informed about new clinical treatments and scientific findings [46:41]

QUESTION: What was most useful for you in this episode?

Leave me a comment below and thanks for listening.

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CTP 006: Journey from Engineer to Clinical Director with Robin Eckert http://clinicaltrialpodcast.com/interview-robin-eckert/ http://clinicaltrialpodcast.com/interview-robin-eckert/#respond Sun, 31 Dec 2017 19:55:17 +0000 http://clinicaltrialpodcast.com/?p=494 “You have to forgive yourself and not expect perfection” – Robin Eckert In this episode, I had the privilege to talk to Robin Eckert. Robin is an engineer by training who later transitioned into clinical safety and clinical trial management. She is a very accomplished individual who has led complex...

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“You have to forgive yourself and not expect perfection” – Robin Eckert

In this episode, I had the privilege to talk to Robin Eckert.

Robin is an engineer by training who later transitioned into clinical safety and clinical trial management.

She is a very accomplished individual who has led complex structural heart medical device trials. Robin is also one of the most creative individuals in the clinical research space.

If you’re a gal (or a guy) wanting to transition into clinical research or change roles at your current company, Robin will inspire you with her personal story.

We wrap up our discussion with top-notch resources in the interventional cardiology space.

I hope you enjoy this interview with Robin as much as I did.

Listen to it on iTunes.
Stream by clicking here.
Download as an MP3 by right-clicking here and choosing “save as.”

Selected Links from the Episode

  • Connect with Robin

LinkedIn

Show Notes:

  • Transitioning from R&D engineering to clinical research [02:39]
  • Leading clinical safety and working independently [10:50]
  • What it takes to switch roles [13:41]
  • Finding mentors within clinical organization [16:08]
  • Creativity in clinical research [19:01]
  • Importance of marketing and messaging in clinical research [23:19]
  • Tips and insights for CROs responsible for creating newsletters [29:18]
  • How to get credibility among your peers, industry, understanding why something is important in the grand scheme of things [35:25]
  • Attending conferences [37:27]

QUESTION: What was most useful for you in this episode?

Leave me a comment below and thanks for listening.

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CTP 005: Health Economics and Outcomes Research with James Hasegawa http://clinicaltrialpodcast.com/interview-james-hasegawa/ http://clinicaltrialpodcast.com/interview-james-hasegawa/#respond Sat, 11 Nov 2017 19:22:05 +0000 http://clinicaltrialpodcast.com/?p=490 “Don’t be afraid to try new things” – James Hasegawa This is a special episode in Health Economics and Outcomes Research (HEOR) with James Hasegawa. James is a director at Abbott and is responsible for HEOR projects. In this episode, James shares insights on how healthcare reimbursement works as it...

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“Don’t be afraid to try new things” – James Hasegawa

This is a special episode in Health Economics and Outcomes Research (HEOR) with James Hasegawa. James is a director at Abbott and is responsible for HEOR projects.

In this episode, James shares insights on how healthcare reimbursement works as it related to clinical trials.

We also dig into the world of Health Technology Assessment (HTA) groups and what it takes to model reimbursement for a medical product.

If you’re interested in breaking from the silos of clinical research and learn about important adjacent functions such as HEOR, this episode is for you.

Do you have a topic idea for my next podcast episode? If so, leave me your suggestion is the comments section below.

Listen to it on iTunes.
Stream by clicking here.
Download as an MP3 by right-clicking here and choosing “save as.”

Selected Links from the Episode

  • Connect with James

LinkedIn

Books Mentioned:

Show Notes:

  • What is Health Economics [01:52]
  • James’s personal story: career path to HEOR [06:09]
  • Daily routine of HEOR professionals [13:26]
  • NICE and other HTA [14:30]
  • HTA in the United States [15:15]
  • HTA vs. MAC [16:30]
  • The future of HEOR [18:59]
  • Hospital Readmissions Reduction Program (HRRP) [19:58]
  • Economic value and what should a medical product start-up do? [24:17]
  • How to find HEOR consultants [25:00]
  • Qualities of HEOR people [28:06]
  • Health economic model: how to make one? [28:57]
  • Working with Medicare Administrative Contractor (MAC) [31:38]
  • The future of HEOR (continued) [33:20]
  • On Big Data [34:57]
  • Leveraging HEOR data in countries such as US and Japan [36:52]
  • How does HTA function in the US [38:26]
  • Resources and guidance documents on HTAs [40:23]
  • HTA review process in Japan [43:30]
  • Trick to learning other therapeutic areas [47:55]

What was most useful for you in this episode? Leave me a comment below and thanks for listening.

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Get A Clinical Research Job – [THE  BEAVER METHOD] http://clinicaltrialpodcast.com/get-a-clinical-research-job/ http://clinicaltrialpodcast.com/get-a-clinical-research-job/#comments Fri, 29 Sep 2017 15:41:14 +0000 http://clinicaltrialpodcast.com/?p=468 Get A Clinical Research Job – [THE  BEAVER METHOD] You spent thousands of dollars on undergraduate or graduate program. You majored in medicine, science or engineering. You even have a GPA of 3.5+ with Honors. But now you’re struggling with getting your into the door at a clinical research organization....

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How To Get Clinical Research Job - The BEAVER MethodGet A Clinical Research Job – [THE  BEAVER METHOD]
  • You spent thousands of dollars on undergraduate or graduate program.
  • You majored in medicine, science or engineering.
  • You even have a GPA of 3.5+ with Honors.

But now you’re struggling with getting your into the door at a clinical research organization. You keep hearing the same lame excuse, “We need someone with two years of clinical research experience.”

Well, how are you supposed to get experience without having a clinical research job in the first place?

I may have a solution for you. In this post, you’ll discover exactly how to land a job in clinical research.

It’s called The BEAVER Method.

But before I explain to you how you can apply this method to your job search, you must first know what NOT to do.

So let’s get started.

#1 Mistake You Shouldn’t Make

The biggest mistake most job searchers make is that they apply for several hundred positions at once.

Yes, you read that right. Applying for several hundred jobs will DECREASE your chances of getting the job.

You don’t want to apply for every-single-job-opening out there. In fact, you only want to apply for 20 or fewer positions.

Let me explain you why.

Applying for more than 20 positions negatively impacts your job search. Here’s why:

  • Not of focusing on handful positions, scatters your mind. And you start to lose focus. According to Tony Robbins, a world-renowned performance coach, you want to control and direct the focus of your mind on what has to be doneIn this case, you want to focus on getting that clinical research position.
  • You are competing with hundreds of other applicants who are doing the exact same thing as you. Therefore you won’t stand out from the crowd, thereby reducing your chance of getting the job. You’ll be lucky if you got called for an interview.

Now let’s get to The BEAVER Method.

If you know anything about beavers or have seen them in action at an aquarium or in the wild, you know they are industrious and hardworking creatures.

I actually also find beavers very cute.

Just like a beaver, I’ll show you have to can work hard and get the results you desire with your clinical research career.

#1: Broaden Your Understanding about Clinical Research

One of the biggest obstacles many entry-level applicants face is in their ability to believe in themselves and their know-how about clinical research.

Below are common reasons why many applicants lack self-confidence:

  • I’ve never worked in clinical research before and don’t know where to start
  • I don’t have the therapeutic or medical knowledge needed to get a job
  • I need get a clinical research certificate before I can apply for a job

The truth of the matter is that they don’t teach clinical research in colleges. Most people get on-the-job experience.

But without self-confidence, you can’t and shouldn’t even consider applying for clinical research jobs. You’ll be flat out rejected.

However here is what you can do to quickly get up to speed on the key fundamentals of clinical research.

Want to Get a Jumpstart with your Job Search? Download the Clinical Research Job Search Tracker

  • Learn about different clinical research roles

Understanding the different clinical research roles will give you a holistic view of your options. You’ll also get a sense of which roles are interesting to you and which ones aren’t.

Many people believe Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) role is the ticket to getting your foot in the door. However, the CRA or CRC role may not be the right fit for you.

There are many other clinical research roles such as biostatisticians, clinical safety monitor, data managers, clinical study (or trial) managers, clinical quality, medical writing and more.

Here is an in-depth article in the various clinical research roles. Spend an afternoon reading it, so you can fully understand your options.

The FDA guidance on Good Clinical Practice (GCP) forms the foundation of how clinical trials must be conducted.

Even if you’re not from the US, this guidance document will serve you well. The overarching concepts of GCP don’t vary as much from country-to-country.

Also, all drug (pharma), device, or biologics clinical trials follow GCP. There are minor nuances depending on the medical product. But nothing significant for you to worry about at this initial stage.

  • Know about Clinical Research “Hot Topics”

There are some issues that are perennial hot topics. Some of these topics include Risk Based Monitoring, Patient Recruitment, Clinical Trial Costs and changing regulations in a given geography.

It helps to have a basic understanding of these pain points as you prepare yourself for the next step in the job search process.

As far as therapeutic or medical product knowledge is concerned, I strongly recommend that you don’t worry about it at this stage.

There is no need to spend hours reading cardiology or oncology textbooks. I’ll explain more on this later.

Want to Get a Jumpstart with your Job Search? Download the Clinical Research Job Search Tracker

#2: Evaluate Potential Employers and Employment Opportunities

As I stated in the beginning of this post, the #1 mistake job applicants make is applying for hundreds of jobs at once.

Instead, you first want to carefully evaluate your options and then narrow down your choices to 10-20 employers at most.

  • Ask Yourself the Right Questions

At this stage in the process, avoid worrying about the following:

  • The company is too big (or too small) for me to get a job
  • The company doesn’t have any clinical research job openings at this time
  • I’ve heard they don’t pay enough
  • The recruiter I spoke with said they’re only looking for candidates with work experience

Instead, here’s what you should be asking yourself the following questions:

  • Can I commute to the office on a daily basis?
  • If needed, am I willing to relocate to a different city, state or country?
  • What salary or hourly rate would be sufficient so I can get my basic needs met (food, clothing, rent)?
  • Any other “must have” requirements such as flex time or medical insurance that will determine whether or not you’ll take the job or not.

Now write down your responses on a piece of paper.

Use the responses to the above questions to guide you through the remaining steps of the job search process.

  • Start Researching Companies

The best way to research companies is to go their website.

But can you get to the website if you don’t even know the company name?

Well, you’re in luck because I have two amazing options for you.

One of my favorite resources is a FREE directory on Biospace.com. You’ll find hundreds of companies listed here. The other option is to use LinkedIn to find potential employers.

Your list of 10-20 companies can be pharmaceutical, biotech, medical device, clinical research organizations or health IT/software companies.

  • Organize Potential Employers

Once you’ve identified these potential employers, type them on an excel spreadsheet. We’ll call this spreadsheet your “Clinical Research Job Search Tracker.”

If any of these employers have job openings that are of interest to you, add the job title to your Job Search Tracker.

Don’t beat yourself up if you find an interesting position but don’t have the experience or knowledge needed for that role yet.

It might also be a good idea for you to print our job descriptions that you find interesting.

#3: Assess the Quality of Your Resume and Linkedin Profile

Now that you have a basic understanding of clinical research and have completed your research on potential employers, it’s time to fine-tune your resume and LinkedIn Profile.

  • Assess the quality of your resume

If you haven’t worked in clinical research before, chances are that you don’t have any clinical research experience to include on your resume.

But you’ll surprise yourself by taking an inventory of your past educational or work experiences.

Below are the types of experiences you want to list on your resume:

  • A research project you’ve been part of or led in the past.  The size of the project doesn’t matter. You can write about a project that lasted for just 4 hours or one that involved only two people.
  • Be specific about YOUR role on this project. If you led a specific aspect of the project or led the team, write that down.
  • Any scientific and non-scientific publications or articles you’ve written. Writing is an important skill that most, if not all, employers value greatly.
  • Any presentations you’ve done.
  • Any volunteer work you’ve done in the medical or non-medical field.

Clinical research is a team-oriented industry. If you can demonstrate that you have strong written and verbal communication skills, you’ve won half the battle.

I find many fresh graduates write down the course names on their resume. This approach, in my opinion, is a completely useless.

If you took a Bioengineering 101 course in college, it tells the employer nothing about your skills. However, if you write down details about a specific project you did as part of this course, now it becomes more interesting and useful piece of information for the recruiter or hiring manager.

So in summary, write about different projects you’ve undertaken in the past. The more specific you can be about your contributions and the outcome of the project, the better.

Want to Get a Jumpstart with your Job Search? Download the Clinical Research Job Search Tracker

Other general resume rules that you must not break:

  • Keep your resume short, no more than 1-2 pages
  • Use bullets to make it easier for employers to read your resume
  • Typos, grammatical and spelling errors are generally not tolerated
  • Use consistent line spacing, font size, and formatting throughout your resume
  • Use free tools like Canva.com to create beautiful resumes

If don’t know how to write a resume or need help reviewing it, your career services or local library may offer this service for free. All you need to do is ask for resume help.

  • Create a solid LinkedIn profile

LinkedIn is your digital resume. If your LinkedIn profile isn’t exceptional, you’ll miss out on potential employment opportunities.

There are many blogs and books written on LinkedIn profiles but I find the following to elements to be most critical:

  • Professional Quality Headshot

The first thing a potential employer will see on your LinkedIn profile is your face. So be sure to have a professional quality headshot (and don’t forget to smile).

You don’t want headshot with a busy background, showing you having fun at the bar with your friends, or pixelated. 

Pay a professional photographer for a stellar headshot.

  • Add a Summary

In this section of your LinkedIn profile, you should summarize what you’ve learned and achieved in your previous academic or professional experience.

If your experience is not related to clinical research, describe how you’ll extend your experiences and skills to clinical research.

Make your summary section relevant to the clinical research industry.

  • Featured Skills, Endorsements, and Recommendations

Ask your professors or colleagues for public endorsements and recommendations on LinkedIn.

When it comes to current and previous work colleagues, I would encourage that you first endorse and recommend them on LinkedIn and see if they would consider returning the favor.

You may also want to tailor these sections of your LinkedIn profile to match the clinical position job requirements or qualifications.

#4: Vow to Create and Use a Job Search Tracker

The Clinical Research Job Search Tracker is the crux of The BEAVER Method.  This is the same spreadsheet that you created in step # 2 “Evaluate Potential Employers and Employment Opportunities” described above.

  • What Is a Clinical Research Job Search Tracker?

A “Clinical Research Job Search Tracker” is a systematic way for you to organize contacts, company information, key communications and follow-up dates.

You’ve done your research and are now ready to apply for jobs and build relationships with potential employers.

Very soon you’ll be sending emails or calling potential employers. But if you don’t follow-up in a systematic way, you’ll get nowhere.

You have the option of trying to remember your last conversations and then follow-up accordingly. However, I find the “trying to remember” approach very stressful.

As humans, it’s hard for us to stay disciplined, especially when it comes to things we don’t really enjoy doing such as a job search.

This tracker, as boring as it may be, will help you stay focused and keep you on track with your job search.

  • How To Create and Use a Job Search Tracker?

The “Clinical Research Job Search Tracker” can be a Google Sheet that resides in your Google Drive or a Microsoft Excel spreadsheet that you save on your computer. The advantage of a Google Sheet is that you can access it from anywhere and it remains saved in the cloud.

The key column headers of the “Clinical Research Job Search Tracker” are as follows:

  • Company name
  • Position/ Job Title
  • Hiring Manager/ Recruiter/ Director/ VP First Name
  • Hiring Manager/ Recruiter/ Director/ VP Phone Number
  • Hiring Manager/ Recruiter/ Director/ VP Email
  • Hiring Manager/ Recruiter/ Director/ VP LinkedIn URL
  • Date of Last Contact
  • Contact Type: Email, Phone, Other
  • Next Follow-up Date
  • Remarks
  • Status: Phone Interview, Interview Round #1, Interview Round #2, Declined, On-Hold

You can get creative and use colors to denote the status of various items in this spreadsheet. You can also add more columns as you see fit.

The main thing here is that you want to use this spreadsheet religiously (even if you’re not a religious person).

  • Benefits of a Clinical Research Job Search Tracker

Here the some of the benefits of keeping a job search tracker:

  • Keeps you organized with your job search and outreach efforts
  • Ensures you have a clear plan on who you need to communicate with and when you need to follow-up
  • Maintains a history of the communications you’ve had with the employer.

Trust me it gets very confusing, even with 10-20 employers.

Want to Get a Jumpstart with your Job Search? Download the Clinical Research Job Search Tracker

#5: Engage With Other Clinical Research Professionals

By the time you get to this step in the process, you’ve already put in a ton of work into planning for your job search.

The heavy lifting is done and now you’re ready to reach out to potential employers and apply for jobs.

There are four fundamental through which you can build relationships with potential employers and land a job interview.

  • Schedule Informational Interviews

Through your research, you’ve identified potential employers. Now you need to reach out to people at these companies and schedule informational interviews.

The informational interviews can be in-person or via phone. When you reach out to individuals for informational interviews, be clear that you are not asking them for a job.

The purpose of an informational interview is to understand the hiring process, skills that are important to the employer, types of candidates that make it through the interview process and the organization’s culture.

If you end up meeting in-person, be generous and pay for coffee or lunch. Yes, it will cost you a few dollars that you don’t have. But this act will pay huge dividends in the long run. Plus don’t forget that this person is taking time off from their busy schedule to meet with you.

Use tools like hunter.io or elucify.com to find email addresses of individuals you want to connect with.

  • Join LinkedIn Groups and be an Active Participant

One of the best ways to connect with other clinical research professionals is LinkedIn Groups such the Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Professionals (SOCRA).

You may also want to search for niche LinkedIn groups that are specific for a given therapeutic area or medical product you’re interested in.

Once you’ve joined the group, take the time to read the latest posts in the group and start engaging. The simplest way to engage with others in the group is to make thoughtful comments or ask insightful questions.

People in the group will start noticing you and then you can reach out to those people for an informational interview as described above.

When people are in the same LinkedIn group, they already feel connected to each other and are more likely to meet with you or have a phone call.

  • Reach out to People with Director Title or above

This is my favorite tip for engaging with decision makers in the clinical research. My advice to you is to go all the way to the top!

Email and call directors, vice presidents or even CEOs depending on the size of the company.

When you reach out to high-level management, don’t send them your resume right away. Instead, ask them if they would be willing to schedule a call or in-person meeting with you.

Sound energetic and enthusiastic and clearly express why you’re interested in working at their company. If you can convey your passion and desire to work for them, your chances of getting an interview will increase manyfold.

The other key reason for reaching to the people on the top is that they are the ultimate decision-makers when it comes to hiring. Who doesn’t want great people to work on their teams?

  • Surround Yourself with Clinical Researchers Who Can Help You with Your Career

You the average of five people you surround yourself with. If you want to become a clinical research professional, then you need to surround yourself with other clinical research professionals.

There are many ways to achieve this. One of the most effective ways is to attend a clinical research national or regional conference.

If money is an issue, email the conference manager and find out if you can volunteer at the event and get a complimentary pass in exchange.

#6: Reinforce Your Interest in the Company and the Clinical Research Position

Once you’ve started to make connections and experienced a few informational interviews, you’ll a get a feel for different employers and what they are looking for.

Using your “Clinical Research Job Search Tracker” as your compass, apply for clinical research roles that you think you are ready to take on right away or can grow into the role in 6-12 months time.

If you meet close to 80% of the job requirements in the job description, I would encourage you to apply. When it comes to prior experience, think about ways you’ve met the job requirements through your previous academic and professional experiences.

The key here is to be able to articulate how your previous experiences make you best suited for the role you’re applying for.

  • Follow-ups – The Holy Grail to Landing a Job Interview

Follow-ups with potential employers via personalized email and phone communication is the only way you can differentiate yourself from other job applicants.

When you follow-up with employers, write the down the key points you want to bring up during your call before you dial the number. If the person doesn’t answer the phone, leave a voice message with your full name, the purpose of the call and your callback number.

When you call an employer or recruiter thinking they are doing you a favor by offering you a job, your voice will soften and your heart will beat faster. Don’t let this happen to you.

Jobs are a two-way street. The employer needs you and you need them. You must sound confident on the phone or on email.

Once you follow-up, type in the date and conclusions from your follow-up on the “Clinical Research Job Search Tracker.”

Some employers will ask you to contact them at a later date, some will respond by saying they are not interested and others will never respond to your follow-up.

For people that don’t reply, you can follow-up every 3 business days. I usually like to follow-up till I hear a “No, we’re not interested” but in general, you can stop following up if you don’t get a response back after 3-5 follow-up attempts.

For larger organizations with many departments and divisions, a “No” from one department or division, doesn’t mean it’s a “No” from other departments or divisions. You want to be consistent (and persistent) with your follow-ups and look broadly when it comes to larger companies.

Want to Get a Jumpstart with your Job Search? Download the Clinical Research Job Search Tracker

Conclusion:

Now that you have an in-depth understanding of The BEAVER Method, it’s time to put your learnings into action.

In order to get a job in clinical research, you want to tackle your job search in ways other applicants are not.

  • Broaden your understanding of clinical research by learning about various clinical research roles, reading the FDA guidance on Good Clinical Practice and increasing your familiarity with hot topics in the industry.
  • Evaluate potential employers and employment opportunities by asking yourself the right questions, researching companies you want to work at and organizing potential employers using the “Clinical Research Job Search Tracker”.
  • Assess the quality of your resume and LinkedIn profile. Focus on projects you’ve led or been part of and detail out your role on each of those projects.
  • Vow to create and use a job search tracker to keep track of potential employers and communications with the companies you are applying for jobs at.
  • Engage with other clinical research professionals by scheduling informational interviews, actively participating in LinkedIn groups, reaching out to senior leadership at various clinical research organizations and surrounding yourself with people who can help you in your career
  • Reinforce your interest in a company and the clinical research position you’re applying for by consistently and persistently following up with the right decision makers.

Let me know what you think about The BEAVER Method. I can’t wait to hear about your success.

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CTP 004: 13 Suggestions for Becoming a Great Clinical Project Manager http://clinicaltrialpodcast.com/clinical-project-manager-role/ http://clinicaltrialpodcast.com/clinical-project-manager-role/#comments Mon, 28 Aug 2017 14:08:36 +0000 http://clinicaltrialpodcast.com/?p=449 This is a solo episode where I share with you “13 Suggestions for Becoming a Great Clinical Project Manager.” If you are currently clinical project manager or desire to transition into the clinical project manager role, this episode is for you. This episode will also serve well for those interested...

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This is a solo episode where I share with you “13 Suggestions for Becoming a Great Clinical Project Manager.”

If you are currently clinical project manager or desire to transition into the clinical project manager role, this episode is for you. This episode will also serve well for those interested in learning about what are the roles and responsibilities of a clinical project manager.

In this episode, I’ll share with you the fundamentals, tactics and soft skills that turn a good project manager into a great project manager.

At the most basic level, a project manager must be familiar with the clinical study protocol, clinical study procedure(s), and Good Clinical Practice (GCP) requirements.

Next, a clinical project manager needs to be savvy with creating and managing study budgets, timelines and resources.

Finally, the soft skills make a world of a difference between a good project manager and a great project manager. I’ll share with you 6 specific soft skills that will help you exponentially if you are really serious about the clinical project manager role.

Thanks to my blog reader Christopher B. for recommending this topic.

Do you have a topic idea for my next podcast episode? If so, leave me your suggestion is the comments section below.

About This Podcast Episode:

Listen to it on iTunes.
Stream by clicking here.
Download as an MP3 by right-clicking here and choosing “save as.”

Selected Links from the Episode:

  • Connect with me (Kunal)

LinkedIn | Twitter

Books Mentioned:

Show Notes:

  • Protocol, follow-up requirements and adverse event reporting [01:26]
  • Understanding the clinical procedure [4:42]
  • Good Clinical Practice [6:02]
  • Managing a clinical study budget [7:20]
  • Proficiency with Microsoft Excel [8:22]
  • Developing and executing on study timelines [14:41]
  • Managing study resources [22:05]
  • Paying attention to compliance [24:02]
  • Being self-aware [28:13]
  • Being objective in your decision-making process [29:40]
  • Being proactive and results driven [31:04]
  • Ask questions and be curious [32:58]
  • Explain your thought process [36:40]
  • How to communicate effectively [38:05]

QUESTION: What was your favorite lesson from this episode?

Leave me a comment below and thanks for listening.

The post CTP 004: 13 Suggestions for Becoming a Great Clinical Project Manager appeared first on Clinical Trial Podcast.

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CTP 003: Conversation with Clinical Development Veteran Marshall Cool http://clinicaltrialpodcast.com/interview-marshall-cool/ http://clinicaltrialpodcast.com/interview-marshall-cool/#respond Sat, 19 Aug 2017 23:54:20 +0000 http://clinicaltrialpodcast.com/?p=395 Conversation with Clinical Development Veteran Marshall Cool “There are a lot of things we can do, but we want to make sure we’re doing what we want to do” – Marshall Cool In this interview, I talk to one of my dear friends Marshall Cool, who also turns out to be...

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Conversation with Clinical Development Veteran Marshall Cool

“There are a lot of things we can do, but we want to make sure we’re doing what we want to do” – Marshall Cool

In this interview, I talk to one of my dear friends Marshall Cool, who also turns out to be a clinical research veteran.

Marshall brings to us his over two decades of clinical development experience, including his time at Abbott Vascular, leading one of the most exciting post-approval medical device studies, XIENCE V USA.

Marshall also has significant experience managing Investigator Sponsored Studies (ISS) and clinical research organizations, details of which he shares with us during this interview.

In addition, Marshall is an avid reader and loves books.

Please enjoy my conversation with Marshall Cool.

Listen to it on iTunes.
Stream by clicking here.
Download as an MP3 by right-clicking here and choosing “save as.”

Selected Links from the Episode:

  • Connect with Marshall Cool

LinkedIn

Books Mentioned:

Show Notes:

  • Description of what a clinical researcher does [02:10]
  • Early days in clinical research [04:23]
  • Roles and responsibilities of a clinical research associate (CRA) [08:55]
  • You don’t need an M.D. or Ph.D. to be in clinical research [10:55]
  • Relocating for jobs [13:20]
  • Transition from pharma to medical device clinical trials [15:55]
  • What to do when you lose your job [19:46]
  • Getting into the habit of reading and how it can help your clinical research job [26:31]
  • Getting to First Patient In (FPI) for a post-approval medical device study [31:50]
  • Onboarding a clinical research organization (CRO) [39:15]
  • Investigator sponsored studies (non-company sponsored research) [41:30]
  • Starting your career in Phase I-III research [45:45]
  • Marshall’s #1 advice to listeners [56:30]
  • My motivations for starting the Clinical Trial Podcast [1:01:33]

QUESTION: What was your favorite lesson from this episode?

Leave me a comment below and thanks for listening.

 

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CTP 002: Hidden Opportunities in Clinical Research with Gary Thompson http://clinicaltrialpodcast.com/interview-gary-thompson/ http://clinicaltrialpodcast.com/interview-gary-thompson/#respond Wed, 16 Aug 2017 20:44:33 +0000 http://clinicaltrialpodcast.com/?p=368 “Life is an adventure” – Gary Thompson In this interview, I had the pleasure to speak with one of the most optimistic individuals on the planet, Gary Thompson. Gary is the Vice President of Clinical Research at Abbott Vascular. In this interview, Gary shares a ton of valuable information on...

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“Life is an adventure” – Gary Thompson

In this interview, I had the pleasure to speak with one of the most optimistic individuals on the planet, Gary Thompson.

Gary is the Vice President of Clinical Research at Abbott Vascular. In this interview, Gary shares a ton of valuable information on career choices, his #1 advice for all managers, and the relationship between money and happiness.

In his free time, Gary loves to sail and is a proud owner of two sailboats. We discuss how sailing and clinical research are related in more ways than you can imagine.

Enjoy my interview with Gary!

Selected Links from the Episode

Show Notes:

  • Advice on how to get into clinical research [1:20]
  • Working in Japan [7:33]
  • In-direct career paths [11:10]
  • How to decide when considering a new clinical role [13:12]
  • What it takes to work in a new geography [19:22]
  • Most valuable lesson for all managers [23:26]
  • Succeeding in the absence of a typical American childhood [25:56]
  • Importance of work life balance [28:38]
  • On sailing and how it applies to clinical research [32:46]
  • Why you should take time off [41:44]
  • Being present and meditation [43:30]
  • Calling friends and family during the daily commute [47:20]
  • Taking advantage of the right opportunities [57:30]

QUESTION: What was your favorite lesson from this episode?

Leave me a comment below and thanks for listening.

The post CTP 002: Hidden Opportunities in Clinical Research with Gary Thompson appeared first on Clinical Trial Podcast.

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CTP 001: Becoming an Intelligent Clinical Researcher with David Rutledge http://clinicaltrialpodcast.com/interview-david-rutledge/ http://clinicaltrialpodcast.com/interview-david-rutledge/#comments Sun, 13 Aug 2017 18:00:49 +0000 http://clinicaltrialpodcast.com/?p=246 In this episode, David and I talk about his work in quality, clinical and regulatory affairs. We dig deep into his academic and industry roles, his experience in China and importance of continuous learning.

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Download Episode

“It’s important to make things clear and also look at it from the lens of public health not just from the lens of business.” – David Rutledge

“Don’t let the place you begin dictate the place you end up” – David Rutledge

My guest on today’s podcast is David Rutledge. David is a Regulatory Affairs Director at Abbott Vascular.

David is an expert in Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) which form the foundation of medical product approvals and license renewals worldwide.

In his previous role as a Clinical Research Director, David has led publications strategy for Abbott’s medical products including the blockbuster XIENCE V drug eluting stent. David has also served on the FDA advisory committee for four years prior his industry experience.

David is my go-to person for advice on interpretation of Meddev regulations and the Medical Device Regulation (MDR). He is also a regulatory and quality expert presenting at many conferences and providing input on draft regulatory guidance documents.

Enjoy my interview with David!

Selected Links from the Episode:

  • Connect with David Rutledge

LinkedIn

Books Mentioned:

Show Notes:

  • How to pierce through clinical study reports and making insightful comments [09:45]
  • About Six Sigma certification [17:05]
  • Three basic skills that will make you a better CRO or medical writer [21:59]
  • Developing competency in quality systems [31:05]
  • Paying for certifications and training [34:40]
  • Guidance for productive one-on-one meetings with managers [37:00]
  • Learning from the mistakes of others [40:18]
  • Keeping current with latest developments in clinical research industry [42:41]
  • Working in China and the CFDA [52:20]
  • Taking ownership of your career [1:02:45]

QUESTION: What was your favorite lesson from this episode?

Leave me a comment below and thanks for listening.

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Who’s Who In Clinical Research http://clinicaltrialpodcast.com/clinical-research/ http://clinicaltrialpodcast.com/clinical-research/#comments Thu, 20 Apr 2017 18:00:36 +0000 http://clinicaltrialpodcast.com/?p=323 Who’s Who In Clinical Research Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical...

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clinical research

Who’s Who In Clinical Research

Almost everyone I’ve met in clinical research has accidentally discovered this hidden profession. Your interest in science and medicine somehow got you involved in clinical research and clinical trial management. But didn’t you wish you had a crystal clear understanding of “Who’s Who In Clinical Research?”

That’s when this post come handy.

Clinical Research is sometimes also referred as Medical Affairs or Clinical Affairs. Aside from the naming nuances, the pillars of clinical research remain the same. This is true for pharmaceuticals, medical devices and biologics.

In this article, you’ll learn the functional areas that form an ideal clinical research team at a sponsor or clinical research organization (CRO). For each function, I’ve highlighted why the group exists and their general mindset.

We’ll wrap up our discussion with adjacent departments that interact with clinical research professionals.

So let’s get started:

  • Project Management

I wanted start with my personal favorite clinical research function, Project Management. The reason why project management team is so interesting is because it provides an holistic view of clinical trial management and clinical research.

“General Contractor” for the study

The project management team is made up of Clinical Project Managers and Program Managers. In some companies, Clinical Project Managers (CPM) may be referred to as Clinical Trial Managers (CTM) or Study Managers.

Project managers are the “General Contractors” of clinical research. They are accountable of all aspects of a clinical trial.

Go-to person for budget, timelines, resources

Developing and actively managing clinical trial finances, timelines and resource allocation is a necessary for a smooth trial execution.  This responsibility falls under the project management team.

After mapping out trial assumptions such as number of sites, patients, enrollment period, monitoring, a project manager will develop the study budget and timeline with key milestones.

Depending on the size and reporting structure of the company, project resources are either managed by the project manager or by functional managers.

Ability to connect the dots

A great project manager is able to connect two seemingly unrelated issues and assess the impact on the project.

Let me give you an example.

Say you’re in the midst of a securing FDA approval to start a new clinical trial. You find out that the FDA has follow-up questions. This is going delay the First Patient In (FPI) date. Your investigational devices with limited shelf-life are ready to be shipped to the sites.

A great PM will recognize the downstream effects of study startup delays. For example, she’ll start planning for the additional devices. Not only that but the PM will also adjust the study budget.

Want to refer to this later? Get this 19-page guide sent to your inbox now.

Anticipates issues

In addition to be able to connect the dots, a project manager also anticipates issues.

For instance, a clinical site may be enrolling at a rapid pace. During a periodic data review meeting, the project manager finds out that the site has significant number of protocol deviations.

Rather than letting the clinical site continue enrollment, the PM decides to put the site enrollment on hold until the compliance issues are fully addressed and resolved.

The PM anticipates the negative impact of compliance issues on the overall trial. If the PM does not anticipate the issue, it could have negative consequences on the final results and major audit findings for both the sponsor and the clinical site.

Can visualize and paint the big picture

A clinical trial has many moving parts. The objective of most trials is secure product approval, indication approval or assess the long term safety of the product after it is approved.

Keeping this end goal in mind, clinical project manager needs to have a thorough understanding of the key milestones. If challenges arise (which they will), the project manager needs to communicate the challenges effectively to the right stakeholders.

It is also not uncommon for a project manager to paint the big picture for the team. This is necessary to prevent the team from digressing on irrelevant topics or getting distracted.

Not afraid to get hands dirty

When I started my career, I felt that project manager’s primary job was to tell other people what to do and by when it needs to be done.

That certainly did not turn out to be true.

Most of us desire a “perfect” project with no issues or challenges. This is however not reality. There will be obstacles along the way that a project manager will need to overcome.

For example, let’s consider a clinical site that urgently needs investigational devices to enroll a patient the next morning. Unfortunately the FedEx package drop-off time is 4:00pm and the pick-up truck has left for the day. The only way to get the device to the site in time for the procedure is to drop off the device package to the airport. A great project manager would drive to the airport and drop off that package.

There are countless such scenarios where the project manager would need to roll up the sleeves and get to work.

  • Operations – In-house

Depending on the organization structure, Operations may be rolled up into Project Management or be a separate function.

Operations may be further subdivided in Internal Operations and External Operations. Members of the operations team usually have titles such as clinical research associate or clinical research manager.

Champions site start-up

In-house operations team is primarily responsible for site start-up. This team ensures that each site has the most recent version of the site start-up packet. The start-up packet consists of the protocol, ICF template, and other study specific documents.

The in-house operations team also facilitates clinical contract negotiation with the site, which includes the study budget.

Understands devil is in the details

Once the study-specific ICF template is sent the sites, the sites personnel review and edit the ICF to meet their site-specific IRB/ Ethics Committee requirements. The redlined ICF is then sent to the in-house operations team for final review and approval.

Similar to the ICF redlines, the CRAs also receive redlines on the clinical contracts.

This means that in-house operations is constantly inundated with multiple documents and redlines. This requires the in-house team to be detailed oriented and organized. An error can have significant ramifications including potential audit findings or lawsuits.

Life revolves site management and support

The in-house operations team is available for site management and support. Aside from ICF and clinical contract questions, it usual for sites to contact their in-house CRA with questions about clinical protocol, study specific requirements, investigational device re-stocking, and more.

  • Operations – Field

A field operations team is composed of field clinical research associate’s (CRA) and clinical research managers. Field CRAs are also known as monitors.

In-house operations and field operations roles can sometimes overlap. In some organizations, field and in-house operations teams are combined into one group, namely Clinical Operations.

Face of the study for clinical sites

A field team is the “face of a study” for a clinical site. Most field operation team members work remotely from their home office. They travel to clinical sites on a regular basis for monitoring and site support.

The field CRA is also responsible for conducting pre-study visits, site initiation visits and study close-out visits.

Understands devil is in the details

A field CRA is responsible for monitoring clinical trial data at the site. A field CRA needs to have thorough understanding of the study protocol, Good Clinical Practice (GCP) and regulations applicable to the conduct of clinical trials.

A clinical trial database has numerous fields. Depending on the monitoring plan, a CRA needs to review and verify the accuracy of the source data at the site.

For example, the CRA ensures the patient informed consent was signed prior to the procedure, serious adverse events were reported on time or protocol deviations were addressed appropriately. This work requires attention to details and deep focus to be done right.

Helps site succeed on all fronts – start-up, enrollment, compliance

Site coordinators can get overwhelmed with multiple trials. Many clinical sites are also nonprofit organization with limited funding and resources to support clinical research.

A field CRA can help their clinical site be successful by promptly answering all questions during study start-up, enrollment and follow-up.

In addition, it’s not uncommon for a CRA to prep sites prior to any scheduled audits.

The job of the field CRA is not “police” the site but rather be the site’s champion and help a site be successful in their research efforts.

  • Data Management

Here’s the deal.

Products are brought to market based on clinical data. Government agencies, medical community and patients believe in the power of data.

It is no easy task to collect and clean hundreds of clinical trial data points in a compliant manner. This is where the data management team comes to play.

Figures out how data will be collected and cleaned

One of the key responsibility of a data manager is to develop case report forms (CRF) for the collection of clinical trial data. These days most data is collected via electronic data capture (EDC) forms.

A well-designed and thought out CRF can be of great value to the sponsor in the long run. For example, data collected in a case report form can not only help secure product or indication approvals but also forms the basis of publications and presentations.

Life revolves around database locks

Once all patients have completed their primary endpoint visit and the data has been cleaned, the final step is to lock the database.

Database lock is a very important milestone not only for data management but also for the entire organization.

Database locks can be a very stressful time for data managers, sites and CRAs. The CRAs are frantically working with the clinical sites to resolve open queries. A database is usually not locked till open queries are resolved.

Once the database lock occurs, the biostatistics is able to analyze the data and generate tables and graphs.

Communicates data metrics

Without data metrics, you would have no way of knowing whether your sites are completing the CRFs in a timely manner.

Let’s consider a 1000 patient clinical study at 65 sites with 3-year patient follow-up. For each patient there are 20-30 case report forms with multiple fields in each form. It becomes increasingly complex to determine what data is missing, incorrectly entered or not available.

A data management team can create custom reports that can provide data metrics by site, by visit or by patient. This information makes it efficient for sites and CRAs to address data entry gaps and query resolution.

Want to refer to this later? Get this 19-page guide sent to your inbox now.

  • Biostatistics

Statisticians are the numerical brain behind a clinical study. Statistics is a very broad field with numerous data analysis methods.

Key driver behind trial design

One of the key components of clinical trial design is the sample size. Simply speaking, you want to know how many patients are needed in order for the clinical study to be statistically sound.

For many studies, regulatory agencies review the statistical analysis plan (SAP) as part of the trial design review.

Life revolves around p-values, trial power and performance goals

P-values, power and performance goals are the geeky pieces of information that statisticians care about.

Statisticians want to understand if the trial results (good or bad) are replicable in the real world.

They attempt to understand the probability of the certain benefits or risks to re-occur in real world once the medical products are commercially available.

Communicates study results numerically using tables and graphs

The Statistical Analysis Plan (SAP) specifies how the data will be analyzed.

Once the clinical data is analyzed, it presented beautifully in the form of tables and graphs. This is a key task as it forms the foundation of how the trial results will be communicated to the outside world.

Tables are graphs are utilized in clinical summary reports, annual updates, presentations and publications. Tables and graphs are also included on product Information For Use (IFU) documents and Patient Guides.

When the product is approved to be sold commercial, sales and marketing teams use government approved tables and graphs to promote the use of the drug or device.

  • Safety

This is a very interesting role for anyone who wants to be closest to the medical aspects of any clinical trial.

Safety touches most aspects of a clinical trial including the protocol, patient informed consent, patient safety outcomes in the final study report, Instructions for Use (IFU) document and more.

Understands regulatory requirements around patient safety

Regulatory agencies are most concerned about the safety of the clinical trial procedure and investigational device or drug.

The safety team has a thorough understanding of regulatory requirements pertaining to the safety of any clinical trial.

When patients are enrolled in a clinical trial, they may experience an adverse event. Clinical sites, sponsors and CROs are required to meet strict adverse event reporting requirements. This requirements can vary by country.

A safety team member has a clear understanding of regulatory requirements and helps ensure safety compliance.

Life revolves around adverse events management

A safety monitor champions all safety aspects of a clinical trial such as adverse events, clinical trial procedure risks, and device/ drug risks.

When a patient participates in a clinical trial, he or she may experience adverse events, also known as AEs. These AEs are reviewed by the safety team.

In some cases, there may be unexpected serious adverse events (SAEs) that may impact patient safety. When such events occur, the safety team evaluates and communicates the adverse event information with stakeholders such as clinical trial sites, patients, and regulatory agencies.

Manages Clinical Events and Data Monitoring Committees

When patients experience AEs, the clinical sites reports the AEs to the trial sponsor or CRO. The safety team reviews reported AEs  and collects relevant medical records.

A subset of these AEs and the corresponding relevant medical records are sent to an physician committee, known as the Clinical Events Committee (CEC). The safety team manages the selection and operation of a CEC.

The basic premise of a clinical trial is that it’s a drug or medical device experiment on human beings. Participation in a clinical trial usually involves safety risks. Some safety risks are anticipated and others aren’t.

For unanticipated risks during the enrollment phase, a sponsor may recruit a data safety monitoring board (DMC). The DMC ensures there is no risk to patients in the trial.

Not all trials require DMC as duration of enrollment might be too small to detect a safety signal. Similar to CEC, the safety team leads the selection and management of a DMC.

Want to refer to this later? Get this 19-page guide sent to your inbox now.

  • Quality

Throughout my career, I’ve worked with clinical quality experts that either “police” every step in the clinical process or serve as a partner and resource to other clinical research functions.

In both cases, the ultimate goal of any clinical quality personnel is to keep you, your clinical trial and your organization out of trouble.

Ensures compliance in all aspects of a clinical trial

As we’ve discussed earlier, clinical research is a highly regulated industry. With regulations, comes compliance. Clinical research professionals need to comply with government regulations, Good Clinical Practice (GCP) and operating procedures.

You may ask, “What’s the purpose of all this compliance”?

Well, the simple answer is that outcome of a clinical trial sets a new medical standard or leads to an update of an existing medical standard.

Would you trust a drug or device that is brought to market based on a non-compliant clinical trial?

Probably not.

Happiness = No Audit Findings

Passing an audit is the ultimate test of any clinical research organization. This is especially true for audits by regulatory agencies.

Audit findings are painful not just for the quality team but for the entire clinical team. Significant audit findings also raise doubts about the robustness of a clinical trial.

Life revolves around Standard Operating Procedures (SOPs)

For instance, in the US, FDA regulations dictate how a clinical trial should be conducted. These regulations form the basis of standard operating procedures (SOPs).

A great quality associate helps a clinical research organization create and maintain a practical set of SOPs.

It is important to note that the burden of creating SOPs does not lie with clinical quality. Other clinical research functions are responsible for drafting and finalizing their own role-specific SOPs.

Understands Corrective and Preventive Action Plan (CAPA)

Since many aspects of clinical trials are managed by humans, the process is prone to errors. Errors can happen due to oversight, gap in a SOP, or mismanagement. A quality personnel initiates a CAPA when errors are discovered.

The goal of a CAPA is to document the error and take necessary steps prevent the error from happening in the future.

CAPAs are frowned up and are never a good thing for any organization. More CAPAs means there is greater risk, which in turn reduces the public’s confidence in the clinical trial outcomes, product or company.

  • Medical Writing

Clinical trial information is communicated with all stakeholders via clinical documents such as the protocol, clinical reports and manuscripts.

A medical writer leads the task for assimilating trial information and putting it together in a logical way.

Understands scientific content

A medical writer has an in-depth understanding of the therapeutic area and previous clinical and preclinical information on the drug or device.

Given the countless number of medical products and trials, it’s not unusual to learn trial or product specific information after joining the project.

Life revolves around writing protocols, reports or manuscripts

As a medical writer, you need to enjoy the process of writing. If you don’t enjoy writing, it will be painful to write several hundred pages of clinical trial documents on a regular basis.

A medical writer has a unique ability to communicate high-level clinical trial strategy vision in a document such a protocol or report.

Regulatory decisions are made based on these documents. Therefore it is extremely important for a writer to understand what regulators are looking for.

Detailed oriented, especially with punctuation, grammar and formatting

A medical writer is responsible for writing key clinical documents such as the protocol, clinical reports, safety charters, and more.

Punctuation, grammatical errors or typos can reduce the reviewers trust in the final document. Such errors make the company look sloppy in front of regulators, clinical sites or trial sponsor.  

Additionally a medical writer needs to master writing software such as Microsoft Word. Inability to effectively use such software will cause issues with document formatting, resulting in delays and frustration.

  • Scientific

A scientist is responsible the clinical trial strategy. In some organizations, the role of the scientist may be combined with that of the medical writer or that of project management.

Brainchild behind overall clinical strategy

Prior to the start of any clinical trial, a lot of work is put into designing a cost-effective, safe and effective study. Depending on the trial design, there may be quite a bit of back-and-forth between the regulator and the sponsor or CRO.

A clinical trial can begin enrolling patients only after the regulatory alignment is obtained. The scientist champions the development of clinical documents and communication necessary to secure this regulatory alignment.

Life revolves around designing a trial that meets the primary endpoint

If you remember your life as a student (or maybe you’re still a student), your final grade on the test depends on how well you do on the finals.

Along the same lines, the success of any clinical trial is determined on whether or not it meets a pre-specified primary endpoint.

The trial endpoints are clearly stated in the protocol. Once the primary endpoint is met, the medical product will most likely be approved for commercialization.

Happiness = Abundance of high quality clinical trial data

The success of a clinical trial is hinged on high quality clinical trial data. But what does “high quality” mean?

High quality data is error free, accurate, and complete. Missing or incomplete data due to missed visits or sloppy data entry can cause headaches for many clinical stakeholders, primarily the clinical scientist.

Also there can be a tendency to collect more data than needed for “just in case” scenarios such as unanticipated requests from regulators or potential for interesting publications in future years.

  • Systems and Solutions

Not too long ago, clinical trial data was collected on paper case report forms. Then it became incredibly hard to manage data queries, keep track of complete forms and manual entry of data from paper into an electronic database.

With the help of technology, electronic data capture (EDC) solutions were developed. Now site staff can directly enter data in the case report forms.

The Systems and Solutions team is responsible for managing clinical technology solutions such as the EDC. They are also responsible for onboarding new technology solutions and retiring old solutions that no longer add value to the organization.

Technology backbone for clinical trials

More than ever before, technology is becoming an integral part of clinical research. The system and solutions group is the technology backbone for clinical trials.

Want to incorporate wearable technology in a clinical study?

Or build an iPhone app to organize study team contact?

Clinical systems and solutions group is your go-to team.

Depending on the size of the company, this role may be separate function within clinical research or part of the information technology (IT) organization.

Areas of focus – Trial Master File, CTMS, EDC, IxRS, and more

Clinical research teams utilize a few core technology solutions such as the Trial Master File (TMF), Clinical Trial Management System (CTMS), Electronic Data Capture (EDC) and Integrated Web/Voice Response System (IxRS).

The TMF allows you to store study and site level documents in electronic format. A CTMS is useful for managing study contact information. EDC allows sponsors to design electronic case report forms and allows sites to remotely enter data into the system. The IxRS serves to register patients to a specific treatment.

In addition, there may be other systems for safety management and reporting, protocol deviation and monitoring visit management.

Understands regulatory requirements for technology solutions

Regulators are interested in ensuring clinical trial technology is compliant with the law.

At the most basic level, technology solutions need to maintain an audit trail, protect patient personal health information (PHI) and encrypt sensitive clinical trial information.

Systems and solutions team needs to have an in-depth understanding of regulatory requirements pertaining to technology solutions.

Regulators such as the FDA frequently publish guidance documents related to a specific technology product. Guidance documents can be easily accessed via the FDA website and can serve as a great resource for anyone wanting to dig deep in a specific clinical technology area.

Want to refer to this later? Get this 19-page guide sent to your inbox now.

  • Senior Management

Senior management is ultimately accountable for the success (or failure) of any clinical trial.

Key senior management functions in a clinical research organization include directors of each of the functional team described above.

Depending on how the organization is structured, a clinical director may oversee more than one clinical trial or clinical function.

Accountable for all aspects of a clinical program

Providing adequate oversight is the key role of a senior manager.

Oversight is not the same thing as “micro managing” an employee or a task. For certain critical deliverables, a senior manager may be more hands-on.

Strategic focus – Budget, Timelines, Resource Allocation, Procedure Compliance, Scientific Robustness

Clinical trial costs can run into millions of dollars. By controlling project timelines and resources, a senior manager can control expenses.

In addition, it is crucial to ensure the trial is conducted in compliance with regulations and internal procedures.

Finally if the study is not scientifically robust, the clinical trial may not get regulatory approval.

It is not possible for one individual to be competent in all these areas. For this reason, a senior management team is needed to collaboratively achieve the strategic goals.

Interested in Key Performance Indicators (KPIs)

Do you have a retirement account?

Or go to the doctor for an annual check-up?

If so, you’re probably paying attention to the performance of your retirement fund or your health over a period of time.

Along the same lines, senior managers are interested in a set of KPIs that track the performance of a clinical trial against a standard or threshold.

For example, regulators want to ensure patients sign the correct version of the informed consent form (ICF). Signing an incorrect ICF version is a major compliance issue. Thus ICF deviation rate can be a KPI.

Since senior managers are not involved in the day-to-day operations of the trial, they assess the health of a project by reviewing KPI metrics. If KPI metrics trend towards non-compliance, senior managers will take steps to address the issues.

Other Adjacent Functions

A clinical department frequently collaborates and seeks help from other teams. The section below covers the key teams that interact and support clinical teams on a regular basis.

Since the focus of this post is clinical research, the role of these adjacent functions has been described keeping in mind the clinical context.

  • Regulatory Affairs

Regulatory Affairs  (RA) is responsible for the regulatory strategy and submissions. For a clinical trial, a RA team member is generally the primary contact person for the regulator such as the US FDA, Japan PMDA, China FDA.

Deep understanding of regulatory process and requirements

Ready to start a clinical trial? Or address clinical trial deficiencies with the regulator?

You’ll want to start with your regulatory affairs team. Clinical trials are conducted in compliance with regulations. RA can educate you on the clinical documents needed to meet regulatory requirements in a given geography.

A regulatory affairs expert has an in-depth understanding of the regulatory process and requirements.

Adept at reviewing and editing clinical submission documents

Once the clinical team has created the necessary documents such as the protocol, statistical analysis plan or the clinical summary report, a regulatory affairs associate performs a detailed review of the documents.

In addition, regulators have specific formatting requirements such as cover letters and forms that need to be completed with every submission.

Focus is on regulatory agency alignment on all aspects of clinical research

There is specific way of communicating clinical trial information with regulators. This communication style is very different from the day-to-day communication amongst clinical research team members. A seasoned regulatory affairs expert understands this nuance and is able to communicate effectively with regulators.

Happiness = product/indication approvals

A success of a regulatory affairs team is measured by product and indication approvals. It’s no easy task to get a product to market, especially for new therapies.

  • Health Economics and Outcomes Research (HEOR)

Getting medical products or indications approvals is always great news.

But here’s the deal.

You need someone to pay for the approved drug or device. If payors such as insurance companies or Medicare are not willing to provide reimbursement, it can significantly hurt a company’s bottom line.

This is where HEOR comes into play. A HEOR team helps create a body of evidence that the new drug or device has health benefits such as improved quality of life.  

Deep understanding of payor process and requirements

A HEOR expert can help you develop a robust protocol and case report, so you can proactively collect the clinical data needed for reimbursement.

HEOR has an in-depth understanding of country specific requirements. Their work leads to maximum medical product reimbursement for the company.

Understands medical product impact on Quality of Life (QoL)

Let’s say your friend experienced a heart attack and got a stent. Now 10 years have passed. Your friend has not experienced any new heart problems. He feels great, goes for a morning run and is able to spend quality time with his family.

How would you rate his quality of life? Excellent, right?

HEOR pays much attention to a patient’s quality of life. In addition to being safe and effective, medical products need to have a positive impact on a patient’s quality of life.

There are many tools available to measure such quality of life. Clinical trials include quality of life questionnaires for patients to complete. This data is then analysed and utilized to secure reimbursement approvals.

Happiness = Maximum product reimbursement

One of the primary roles of the HEOR team is to ensure the medical product receives maximum reimbursement possible.

Reimbursement can vary significantly based on country laws or availability of new health data. For example, Japan offers higher reimbursement for newer medical products but then decreases reimbursement in future years.

  • Clinical Research Organizations (CROs) and Consultants

Some sponsors hire full time staff to manage their trials. Some outsource all clinical research tasks to CROs and consultants. While others may use a combination of internal and external resources.

Supports sponsor by filling in resource and talent gaps

It is expensive to build a full clinical team, especially for an organization with limited financial resources. CROs can help fill the talent gap for each of the clinical research roles discussed in this post.

Work is billable

A major chunk of clinical trial costs is full-time salaries paid for each of clinical roles explained in this post.

CROs and consultants charge by the hour or by deliverable. The “pay by hour” or “pay by deliverable” model gives sponsors greater flexibility and control on expenses.

People that work for a CRO may be full time employees or contractors. At any given time, a CRO or a consultant may be working on multiple projects for different sponsors.

Can help reduce fixed overhead expenses

For smaller organizations, steady cash flow can be an issue. Therefore having a full clinical team means paying for employee salaries, office space, health insurance and other benefits. This can be cost prohibitive.

Hiring a CRO or consultant can reduce fixed expenses, giving companies greater flexibility with their limited resources.

  • Legal

A clinical research cannot be conducted without legal support. You’d open yourself to all sorts of risks if you didn’t have an lawyer on your team.

Complete understanding of legal landscape

A lawyer with clinical research experience has an understanding of intellectual property law (patents, trademarks), legal entities i.e. how the hospitals or supplier are structured from legal standpoint, supplier contracts, subject injury and liabilities, and more.

Happiness = 100% compliance including no lawsuits

A lawyer will be extremely happy if a company is successfully able to conduct a clinical trial in a legally compliant manner.

For instance, there is great risk to patients participating in clinical trials. If the legal language on the informed consent form or clinical trial contract between the site and sponsor is inadequate or unclear, it can lead to lawsuits.

Lawsuits impact the company’s finances, brand and reputation. A legal team ensures the company does not end up in legal troubles with any of clinical trial stakeholders.

Conclusion:

By now you have an in-depth understanding of all clinical research functions and teams that support clinical trials.

Clinical research and clinical trial management involve cross-functional teams. The chart below summarizes the roles of different clinical research team members.

Which clinical research function interests you the most? Leave your response in the comments section below.

clinical research roles and responsibilities

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