Senior/Medical Director (Medical Monitor)
Core
Provides medical oversight of clinical trials to ensure SOPs, client directives, GCP, and regulatory requirements are followed, while supporting business development.
Role type
Senior/Medical Director (Medical Monitor)
Builds
Clinical trial safety data, medical content for reports (CSR, IND/NDA), and risk management activities for marketed products.
Domain
Pharmaceutical industry, Clinical Trials, Pharmacovigilance, Hematology/Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical judgment, safety variable monitoring, protocol interpretation, adverse event review, regulatory compliance, therapeutic training, report writing
Preferred skills
Active medical licensure, clinical trial experience in CRO or pharma, safety/pharmacovigilance experience
Technologies
None stated
Responsibilities
Manage medical aspects of contracted tasks across the pharmaceutical product life-cycle; Monitor safety variables (AE, lab abnormalities, patient status) of clinical studies; Provide medical review of adverse events and serious adverse events; Assist in writing and reviewing clinical study reports and regulatory documents; Provide medical consultation to clients and investigators.
Seniority
Senior, hands-on IC
