Lead medical oversight for assigned clinical studies by serving as primary or backup Medical Monitor, ensuring scientific accuracy and adherence to protocols. Deliver expert medical insight to investigators and cross-functional teams, supporting decision-making throughout trial execution.
Key Responsibilities
- Oversee medical monitoring activities across multiple trials, including review and interpretation of clinical data, safety findings, and eligibility criteria
- Guide study teams through protocol-specific and therapeutic-area training as needed
- Review and validate protocol deviations, ensuring appropriate classification and resolution
- Lead medical data review, including serious adverse events (SAEs), lab abnormalities, and vital sign trends, escalating critical issues when necessary
- Collaborate with Safety and Pharmacovigilance teams on SAE narratives, signal detection, and periodic safety reporting
- Support regulatory submissions such as INDs and contribute to inspection readiness
- Participate in trial design, protocol development, and feasibility assessments for new projects
- Contribute to medical strategy in bid defenses and client proposals
- Maintain and refine standard operating procedures, templates, and study-specific monitoring plans
- Provide medical input into clinical deliverables including tables, listings, figures, and clinical study reports
- Lead project meetings related to medical monitoring and protocol deviations
- Support line management responsibilities for team members within Medical and Scientific Affairs
Qualifications
Candidates must hold a medical degree (MD, DO, or international equivalent) and demonstrate fluency in written and spoken English. A minimum of 5–7 years of experience in the life sciences industry is required, with at least four years focused on clinical trial medical monitoring.
Essential competencies include in-depth knowledge of ICH GCP guidelines, strong critical thinking, and effective communication skills. Proficiency in Microsoft Office is expected. Experience with safety databases such as ARISg or Oracle Argus, and EDC platforms including Medidata, IBM, or Medrio, is advantageous.
Work Environment
This role operates in a fast-paced, evolving setting that values innovation, collaboration, and scientific rigor. The organization promotes a diverse, inclusive, and customer-focused culture, committed to equal opportunity and fair employment practices. Work-life balance and professional development are supported as part of a dynamic career journey.
