Description
Responsibilities:- Extensive interaction with academic thought leaders to optimize clinical trial strategies and clinically manage the conduct of the clinical trials
- Collaborate with Clinical Science and Medical Writing department in the preparation of clinical development plans, protocols, investigator brochures, annual IND reports, clinical study reports, manuscripts, and different scientific presentations
- Work cross-functionally to define, plan and provide Medical Monitoring to clinical development studies including out of hours coverage
- Responsible for analysis of clinical data including safety monitoring in collaboration with Drug Safety
- Review and sign-off clinical documents with respect to medical relevance
Requirements:
- MD, preferably board certified in internal medicine with an active US medical license
- 10+ years' total clinical research experience with at least 5+ years working for a biopharmaceutical organization with primary responsibility for Clinical Research/Medical Monitoring
- Hematology clinical experience is strongly preferred
To find out more about Real please visit www.realstaffing.com