Associate Director, Medical Monitor, Vaccine Research and Development Specialist
4 weeks ago
Role Summary
The clinician medical monitor contributes significantly to providing medical and scientific expertise and oversight for Clinical Trials conducted globally, with a primary focus in Japan and the Asia-Pacific region.
Key Responsibilities
Protocol Design and Strategy
- Contributes medical input during protocol development and updates to the clinical development plan.
- Works closely with medical monitors and study team members to ensure that documents meet regulatory requirements and company policy.
- Provides medical input into country feasibility.
Accountable for Study Safety
- Provides study team with medical advice for all medical issues during risk assessment and mitigation planning.
- Ensures development of and adherence to the Safety Surveillance Review Plan (SSRP).
- Monitors study safety issues and provides input to serious adverse events (SAEs) reports.
- Communicates safety information to sites across the study.
Supporting the Study Team
- Provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, and data quality planning.
- Contributes to contract research organization/vendor selection to ensure study is conducted consistently with protocol requirements.
- Works with the study team to ensure high-quality data.
Interacting with Regulatory Authorities and Key Opinion Leaders
- Supports Clinical Regulatory Authority interactions, particularly with the PMDA.
- Liaises with Key Opinion Leaders and Principal Investigators to build a network for new trials.
Qualifications
- Medical degree (M.D or equivalent).
- Licensed to prescribe medicines and has utilized the license in a patient care setting.
- Excellent written and oral communication in English and Japanese.
- Understanding of clinical program design, development, and execution.
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