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Senior Director, Vaccine Clinical Research & Development (MD Required)
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Full-time
- The clinician medical monitor is accountable for providing medical and scientific expertise and oversight for clinical trials and serves as a single point of accountability for design, execution, monitoring, delivery and reporting of one or more clinical studies and to ensure patient safety.
- In addition to study level activities, the clinician medical monitor will participate in standing committees, review opportunities for potential in-licensing, including performance of due diligence reviews, and aid new business development on market opportunities and the target product profile.
- Provide study team with medical advice for all medical issues during risk assessment and mitigation planning to enable quality, compliance and patient safety at the trial, site and patient level.
- Reviews literature as needed to respond to safety questions or those posed by the Safety Review Team, Data Monitoring Committee (DMC) or other individuals or bodies involved with the study.
- Ensures the medical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer and accountable for overall quality and timeliness of analysis and reporting are conducted appropriately.
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