Medical Monitor

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 environment as individual contributors