Medical Monitor ( Part-time 10-20 hours/week)
Responsibilities:
- Serve as Medical Monitor for assigned clinical trials
- Participate in drafting study protocols with medical writing
- Draft Clinical Study Reports and Investigator Brochures (IB)
- Assist in the design and conduct of clinical trials including the drafting of protocols and amendments.
- Work closely with the Drug Safety team reviewing and providing medical input into safety reports including all SAE and AESI narratives, analysis of similar events, and Suspected Unexpected Serious Adverse Reactions (SUSARs) reports
Requirements:
- MD with 5- 10 years' direct experience in the pharmaceutical or biotechnology industry in a medical monitoring role
- Experience with vaccine clinical trials
- executing clinical development studies, identify core issues and obstacles for the clinical development of a designated indication and to critically evaluate outside expert advice
- Strong understanding thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines are essential as well as knowledge of ex-US regulatory processes.
- Must possess the ability to provide scientific and clinical expertise to a clinical development program.
- Excellent verbal and written communication skills.
- Strong scientific writer.
If interested in the Part-time Medical Monitor position, apply now!
