Medical Monitor

3 days ago

Ahmedabad Gandhinagar, India Brillex Clinical Research Pvt. Ltd. Full time ₹ 12,00,000 - ₹ 24,00,000 per year

Job Summary

The Medical Monitor will serve as the primary medical expert for late-phase (Phase IIIV) clinical trials, ensuring subject safety, scientific integrity, and regulatory compliance throughout the study. This role involves providing ongoing medical oversight, safety data review, protocol compliance assessment, and guidance to investigators and the clinical team. The Medical Monitor acts as the key medical contact for study teams, sites, sponsors, and regulatory authorities.

Key Responsibilities

Provide continuous medical and scientific oversight for late-phase clinical studies.

Ensure subject safety through regular review of adverse events, SAEs, and safety signals.

Conduct medical data review of patient profiles, laboratory results, and efficacy/safety endpoints.

Support protocol development, amendments, and review of study documents (ICF, CRFs, SAPs, CSRs).

Advise investigators on subject eligibility, protocol compliance, and management of study-related medical issues.

Participate in medical monitoring calls, safety review meetings, and Data Safety Monitoring Boards (DSMBs), if applicable.

Collaborate with project managers, CRAs, and sponsor teams to ensure study timelines and quality deliverables.

Provide medical input for regulatory queries, clinical study reports, and publications.

Train and mentor PI and clinical staff on protocol and therapeutic area.

Perform onsite Medical Monitoring Visit as per MSA

Education - MBBS/MD Pharmacology

Experience Requirement - 1-2 Years

Skills

Strong clinical knowledge and ability to interpret safety and efficacy data.

Excellent understanding of GCP, ICH guidelines, and regulatory requirements for late-phase trials.

Analytical and detail-oriented with sound clinical judgment.

Effective communicator with ability to interact with investigators, sponsors, and cross-functional teams.

Proficiency in medical writing, safety data interpretation, and protocol compliance review.

Ability to manage multiple trials simultaneously and work under strict timelines.

Preferred Certifications

Advanced training or certification in Clinical Research/Drug Development

Pharmacovigilance or Safety Monitoring certification

Therapeutic areaspecific training (e.g., oncology, cardiology, endocrinology) will be an added advantage

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