Clinician Medical Monitor

The Clinician Medical Monitor (CMM) 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. Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.

RESPONSIBILITIES
Accountable for safety across the study:

- Ensures development of and adherence to the Safety Review Plan; Consistent with the plan, performs and documents regular review of individual subject safety data, and performs review of cumulative safety data with the Safety Risk Lead. As appropriate, the CMM may delegate these responsibilities to the study clinician scientist identified in the plan.
- Monitor study safety issues and provide input to reports.
- Evaluate medical benefits/risks to support targeted clinical indications
- 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

Protocol Design and Strategy:

- Provide medical input during development and updates to the clinical development plan
- Designs clinical studies to meet the stated objectives. Assures that clinical trial objectives fit with the clinical program strategy.
- Ensure that documents meet regulatory requirements and company policy
- Provides clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, informed consent documents, clinical review forms, data edit checks, data quality planning, as needed (ultimately oversees work of protocol/study team )
- Develop and maintain peer to peer relationships with healthcare professionals at clinical trial sites
- Contributes to vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied
- Works with study team to ensure high quality of data, as study is ongoing.
- Conducts 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; accountable for overall quality and timeliness of analysis and reporting
- Responsible for medical and scientific validity of study report, especially conclusions regarding efficacy and safety. Responsible for disclosure of appropriate safety and efficacy data and conclusions in results database.
- Provides protocol specific training to study team, Investigators, and others
- Interact with healthcare professionals at sites during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level
- Interacts with Data Monitoring Committees and steering committees as required
- Coordinates medical opinions with other physicians globally to ensure consistency
- Notify appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.
- Monitor investigator compliance with protocol and regulatory requirements

SKILLS:

QUALIFICATIONS

- Medical Doctor (MD) degree required, subspecialty and certification is highly desirable.
- Prior vaccines clinical trials experience a plus
- At least 5 years pharmaceutical industry