Senior Medical Monitor Manager
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Job Description
Senior Medical Monitor overseeing clinical trial safety, medical review, and regulatory interactions for Emerald Clinical Trials. Supporting global clinical research across renal, cardiometabolic, and oncology therapies.
Responsibilities:
- Provide medical oversight and support for clinical trials in accordance with GCP and study protocols
- Act as senior medical contact for clinical development, protocol input, medical review, safety assessment, and client/regulatory interactions
- Review and provide medical input on protocols, informed consent forms, Investigator’s Brochures, statistical analysis plans, and other study documents
- Participate in study start-up, monitoring, and closeout activities as needed
- Provide medical training and support to monitors and project teams, including investigator meetings and safety/data monitoring committees
- Conduct medical review of clinical data and identify data quality or safety issues
- Assess and manage adverse events and serious adverse events, including medical adjudication, causality assessment, and follow-up recommendations
- Prepare and review medical reports
- Communicate with investigators, sponsors, safety monitoring committees, pharmacovigilance teams, and regulatory authorities
- Serve as company medical representative in client meetings, RFPs, and communications with ethics committees and regulators
- Conduct product safety monitoring and prepare or review safety reports, Risk Management Plans, DSURs, and PSURs
- Collaborate with Medical Directors/Managers and drug safety teams to evaluate and resolve safety issues
- Complete other activities assigned by the Medical Director
Requirements:
- Master degree in Medicine
- Minimum 2 years of hands-on medical practice experience, excluding experience gained during postgraduate studies
- 7–10 years or above working experience
- 5+ years of medical monitoring or medical manager experience
- CRO or sponsor experience preferred
- Fluent verbal and written English
- Ability to work independently and handle multiple tasks simultaneously under pressure
- Excellent communication, cross-functional coordination, and problem-solving skills
- Global, cross-cultural perspective and customer-oriented approach
- Knowledge of GCP and clinical trial processes
- Ability to communicate with international clients and regulators
Benefits:
- Competitive salary and benefits package tailored to skills and experience
- Hybrid or remote working arrangements, depending on location and role
- Learning opportunities and access to a global network of scientific leaders
- Employee wellbeing programs and initiatives promoting work-life balance, health, and team connection
- Global engagement surveys
- Recognition programs
- Team-building events
- Exposure to diverse international projects and clients
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