Medical Affairs Manager to join our team in Navi Mumbai, India (office-based). The role involves medical monitoring, clinical trial oversight, safety review, clinical data interpretation, and scientific support across assigned studies, working under the guidance of the Medical Director.

Key Responsibilities Medical Monitoring &

• Study Delivery: Manage routine medical monitoring across assigned clinical studies in accordance with protocols, medical monitoring plans, SOPs, and sponsor requirements. Review subject eligibility, medical history, laboratory results, vital signs, adverse events, and protocol deviations. Provide medical guidance to investigators and study teams. Safety Review &

• Coordination: Review AE/SAE information, clinical findings, safety narratives, and emerging safety concerns. Coordinate with clinical operations, data management, pharmacovigilance, and sponsors to ensure timely assessment, documentation, and escalation of safety issues. Clinical Development &

• Scientific Review: Provide medical and scientific input into study concepts, feasibility assessments, protocol development, study endpoints, and schedules of assessments. Critically review and interpret clinical trial data, Investigator's Brochures, Clinical Study Reports, and other scientific documents for medical accuracy and consistency. RWE &

• Service Development: Support the design and medical review of observational studies, registries, and real-world evidence programmes.



Contribute scientific input to proposals, capability presentations, and scope-of-work development. Quality &

- Team Coordination: Support the development and maintenance of medical monitoring SOPs, review checklists, and templates. Coordinate with Medical Associates and Medical Writers, mentor junior team members, and contribute to audit and inspection readiness.

Desired Candidate Profile

Location: Based in or willing to relocate to Navi Mumbai, Maharashtra, India. This is an office-based position. Educational Qualifications: MBBS from a recognized institution is required. MD Pharmacology or another relevant postgraduate medical qualification is preferred. Other relevant postgraduate medical qualifications will be considered. Experience: Typically 3–6 years of relevant experience in a CRO, pharmaceutical company, or clinical research organization, preferably involving hands-on medical monitoring, clinical data review, safety assessment, and protocol-related medical oversight. Core Competencies: Solid clinical judgment, sound pharmacology knowledge, and commitment to participant safety. Working knowledge of ICH-GCP, clinical trial protocols, EDC systems, and applicable regulatory requirements. Ability to interpret clinical and laboratory data, critically review scientific documents, and communicate effectively with investigators, sponsors, and cross-functional teams.

📌 Medical Affairs Manager (Mumbai)
🏢 Expecto Health Science
📍 Mumbai