In this episode, I had an epic conversation with an amazing human being who has been a force behind my clinical research knowledge and training.
Jessie is a Project Director at Abbott. She has led several important clinical programs including the approval of Abbott’s flagship medical device, the XIENCE V drug-eluting stent in the United States and Japan.
Jessie is a wizard in clinical research processes and can systemize any broken process. She is also a world-class expert in the selection and management of clinical research organizations (CROs).
In this episode, I had an opportunity to speak with Jessie about how to get into clinical research, outsourcing and supplier management, the evolution of the CRA role and much more.
Please join me in welcome Jessie to the Clinical Trial Podcast.
[02:00] Getting into clinical research via technical roles such as data management and biometrics
[02:30] What makes a great statistician?
[04:15] Experience gained working for a big and small company
[11:38] Writing a statistical analysis plan
[12:05] Making CRO-Sponsor relationship work and how to succeed with outsourcing
[14:00] Getting unstuck – understanding how CROs and sponsors work
[14:58] Identifying clinical safety gaps and plugging in a CRO
[16:55] Protecting yourself as a sponsor when you outsource safety
[18:00] Working with CRO through iterations and why RACI may not work for you
[18:27] Outsourcing clinical events committee (CEC) and data safety committee (DMC)
[22:20] MEDRA coding: how it works, automation, generic versus specific coding
[24:30] Reducing CRO/ outsourcing budget and how to do it?
[27:05] Evolution of CRA role – drafting a protocol to writing reports
[33:00] Key Performance Indicators (KPIs) for a clinical research organization
[33:49] Turnover at a CRO and why it matters
[37:46] Financial KPI – money spent relative to the actions that were supposed to happen with that money
[39:22] Developing a process mindset – 5 major things that need to happen from beginning to end
[42:10] Evaluating employee performance relative to others
[43:55] Standing out by managing a chaotic situation, managing senior management discussions, ability to move the conversation along to get to a conclusion, working on “hot” projects that delivered results
[46:00] Volunteer yourself to get involved
[46:36] Moving beyond conference calls and emails – pick up the phone and talk to someone
[49:45] Clinical research is about working in a field where your work really matters