Clinical Trial Podcast http://clinicaltrialpodcast.com Expert Insights for Clinical Research Professionals Sun, 25 Mar 2018 21:39:58 +0000 en-US hourly 1 https://wordpress.org/?v=4.9.5 CTP 009: Real World Data in Clinical Trials with Manuel Prado http://clinicaltrialpodcast.com/interview-manuel-prado/ http://clinicaltrialpodcast.com/interview-manuel-prado/#respond Sun, 18 Mar 2018 01:43:16 +0000 http://clinicaltrialpodcast.com/?p=547   “We’re at the threshold of an astounding period in medical discovery” – Manuel Prado Manuel Prado is an amazing individual who has founded three companies in the clinical space. He spent much of his youth in Peru and worked in investment banking before transitioning into medical transcription and real-world...

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“We’re at the threshold of an astounding period in medical discovery” – Manuel Prado

Manuel Prado is an amazing individual who has founded three companies in the clinical space. He spent much of his youth in Peru and worked in investment banking before transitioning into medical transcription and real-world data.  Manuel and I had an amazing conversation about how we’re missing a lot of eligible patients in clinical trials by only focusing on EMR and claims data and his solution to address issues with clinical data sources. We also talked about life philosophy, clinical resources that can take your career to a different level and the pace of change in the life sciences industry.

Hope you enjoy my interview with the all amazing Manuel Prado.

About Manuel Prado

Spending much of his youth in Lima, Peru, Manuel Prado attended Southern Methodist University before beginning his career in investment banking. When presented with an opportunity to take a year’s sabbatical to travel the globe, he took it, meeting his now-wife in Thailand before returning to his California home.

Inspired by his cultural journey, Prado soon founded the first of his three companies, VIVA Transcription Corporation, which developed patent-pending technology that brought the company national brand presence in the field of medical transcription, serving over 7,000 physicians across all 50 states and employing more than 400 people globally.

In 2010, Manuel Prado began to transition away from the daily management of VIVA and founded Real Health Data, which provides real-world healthcare insights derived from medical transcription documents. With virtually real-time data coming from over 100,000 physicians across the country from every possible specialty, RealHealthData boasts a client list which includes many of the largest pharmaceutical companies in the world.

Prado is also the founder of Adhearx, a company that collects data from automated phone calls to patients, which reveal the true causes of medication non-adherence.

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

Show Notes:

  • Manuel’s journey into clinical research [01:48]
  • Medical transcription and the problem RealHealthData is trying to solve [05:34]
  • Analyzing claims and EMR data and how it’s impacting recruitment in clinical trials [08:57]
  • What physicians are looking at when making referrals to specialists  [10:54]How clinical data companies can engage with sponsors [19:00]
  • FDA and real-world data [27:52]
  • Impact of real-world data on clinical roles [30:09]
  • The pace of change in life science industry [35:52]
  • Why you should consider journaling [43:17]
  • Sabbatical and surfing [48:17]
  • Passion and life philosophy  [53:17]
  • Where is reliable data coming from and what clinical researchers should focus on [55:29]
  • Morning routine, staying focused and not getting distracted  [59:17]
  • Making mistakes and not failure [1:00:52]
  • Two issues with data sources: Timeliness of data and data on female and minority participants [1:07:00]

QUESTION: What was your favorite lesson from this episode?

Leave me a comment below and thanks for listening.

 

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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.

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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.

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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.

The post CTP 001: Becoming an Intelligent Clinical Researcher with David Rutledge appeared first on Clinical Trial Podcast.

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