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
Solid written and oral communication skills
Self-motivated to work in CT workplace as individual contributors

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