Senior Medical Monitor – Contractor
Location: Remote – India
Department: Medical & Scientific Affairs
Company: Biorasi
Employment Type: Contract
Estimated Salary: ₹40 – ₹60 LPA (based on seniority and remote role in Indian CRO market)
About Biorasi:
Biorasi is an award-winning, full-service CRO driven by innovation, collaboration, and dedication to accelerating new therapies. We offer a dynamic, flexible work culture that values both professional impact and personal well-being. Be part of a team that’s reshaping the clinical research industry.
Key Responsibilities:
Medical Oversight:
Serve as primary or backup Medical Monitor for assigned clinical studies.
Oversee multiple trials, contributing to regulatory documentation (e.g., INDs).
Review subject eligibility and provide expert medical input on study matters.
Clinical & Safety Data Management:
Assess and interpret clinical and safety data, ensuring accuracy and relevance.
Escalate critical safety signals and coordinate responses with Sponsors and sites.
Review SAEs, lab abnormalities, and vital signs for clinical relevance.
Collaboration & Leadership:
Lead Medical Monitoring and protocol deviation review meetings.
Work with pharmacovigilance teams on safety narratives and periodic reports.
Support CSR review, TLF review, and documentation for study closeout.
Strategic & Regulatory Support:
Provide medical insight during protocol development, feasibility, and amendments.
Support bid defense meetings, RFP responses, and cross-functional medical strategy.
Guide SOP creation, review study plans, and help in compliance readiness.
Team & Line Management:
Line management of assigned medical/scientific staff.
Mentor and support professional development of team members.
Assist in regulatory audits and inspections as needed.
Candidate Profile:
Education: MD or international equivalent with valid medical license.
Experience:
5–7 years in life sciences industry; minimum 4 years in medical monitoring.
Strong understanding of GCP, ICH, and regulatory guidelines.
Skills:
Fluent in English (spoken and written).
Expertise with safety systems (ARISg, Argus) and EDC tools (Medidata, Oracle Clinical, etc.).
Advanced skills in Microsoft Office and clinical documentation.
Critical thinking and scientific acumen.
How to Apply:
Apply online at https://biorasi.com or email your resume to careers@biorasi.com.
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Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
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Manila |Croatia :
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