Recruitment Manager at Havoc Consultants
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Medical Monitor - Pharma (0-8 yrs)
1. To provide medical inputs in the protocol design, medical monitoring and safety monitoring of clinical trials conducted (Phase I to IV)
2. Responsible for interacting with KOLs for medical inputs for Feasibility, Protocol writing, Data monitoring committees and other regulatory requirements.
3. Regular interactions with Sponsor's medical team for preparation of study related documents, presentations etc.
4. Responsible for therapeutic and protocol training to the project team.
5. Responsible for interacting with Investigators for patient eligibility & medical monitoring activities.
6. To communicate various safety related aspects with the stake holders i.e. Study team to site, and various regulatory agencies and Sponsor's team.
7. To prepare departmental SOP under the guidance of the Head of Clinical Trials/QA.
8. To assist the Head - Clinical Trials for various medical inputs for RFPs.
9. Preparation or review of documents for regulatory submission like RMP, executive summary