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Key Responsibilities:

- Literature search to prepare, review, and finalization of any clinical/non-clinical document
- Review of feasibility and related request for proposal (RFP) study synopsis
- Review of clinical documents, not limited to protocol, informed consent documents, subject diary, clinical study report and similar other documents etc.
- Preparation and review of medical monitoring plan
- Therapeutic training of all stakeholders and if applicable to the site team via in-person / virtual for safety reporting in clinical trials along with medical monitoring plan and safety monitoring plan
- Participation presentation in Subject Experts Committee (SEC) meeting, PI meet Site Initiation Visit etc.
- Review medical data i.e. eligibility documents, periodic data listing of efficacy and safety variables along with completed CRF data and medical coding of essential study data
- Interacting with Investigators for patient eligibility medical monitoring activities
- Communicate various study related aspects with the stake holders i.e. study team at site, various regulatory agencies and sponsor s medical team




- Interaction discussion with KOL for medical inputs for all clinical documents, data monitoring committees and other regulatory requirements
- Assist in data analysis and identifying risks
- Review of IB, IMPD etc.
- Review of clinical and non-clinical overviews and summaries
- Review of briefing documents for EMA, USFDA and other submissions for various filings i.e. MAA, NDA, 510(k), BLA, 505(b)(2) etc.
- Address sponsor , sites , internal clinical operations team regulatory queries
- Review, author and update SOP and support in global initiatives for ensuring enhanced quality and compliance

Qualifications :

- MD Pharmacology is mandatory
- Minimum 2 years of relevant experience
- Solid written and oral communication skills
- Self-motivated to work in CT environment as individual contributors

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Medical Monitor Professional (Ahmedabad)
🏢 COD Research
📍 Ahmedabad