Medical Monitor
4 weeks ago
Role Summary
The clinician medical monitor contributes to providing medical and scientific expertise and oversight for clinical trials conducted worldwide, with a primary focus in Japan and the Asia-Pacific region.
Key Responsibilities
- Contributes to the medical input during protocol development and updates to the clinical development plan.
- Works closely with other medical monitors and Japan study team members to ensure that documents meet regulatory requirements and company policy.
- Provides medical input into country feasibility.
Accountability for 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.
Support to 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 consistent with protocol requirements.
- Works with study team to ensure high quality of data.
Interactions with Regulatory Authorities and Key Opinion Leaders
- May support Clinical Regulatory Authority interactions, particularly with the PMDA.
- Liaises with Key Opinion Leaders and Principal Investigators in countries to build a Key Opinion Leaders/Principal Investigators network for new trials.
Qualifications
Must have:
- Medical degree (M.D or equivalent).
- Licensed by a health authority to prescribe medicines.
- Excellent written and oral communication in English and Japanese.
- Understanding of the design, development, and execution of clinical programs and studies.
Preferred Qualifications
- Documented work experience/knowledge of statistics.
- Training and experience in infectious diseases and/or infection control in the hospital setting.
- Experience with investigational clinical trials.
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