Medical Monitor Professional

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