Job Description :
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
- Strong written and oral communication skills
- Self-motivated to work in CT workplace as individual contributors

Disclaimer: This job posting has been aggregated

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