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Clinician Medical Monitor

Eingestellt von Synectics

Gesuchte Skills: Support, Design

Projektbeschreibung

The 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.

RESPONSIBILITIES:

- Accountable for safety across the study.
- Ensure development of, and adherence to, the Safety Review Plan (SRP); Consistent with the SRP, perform and document regular review of individual subject safety data, and perform review of cumulative safety data.
- As appropriate, may delegate these responsibilities to the study clinician scientist identified in the SRP.
- Monitor study safety issues and provide input to reports.
- Participate in the Safety Review Team (SRT) to 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.
- Review literature as needed to respond to safety questions.
- Communicate safety information to sites across the study and provide responses to questions on safety.
- Provide medical input during development and updates to the clinical development plan.
- Design clinical studies to meet stated objectives.
- Assure that clinical trial objectives fit with the clinical program strategy.
- Ensure that documents meet regulatory requirements and company policy, and have been reviewed.
- Provide medical input into country feasibility Support Study Team.
- Provide 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.
- Contribute to CRO/vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines.
- Work with study team to ensure high quality of data, as study is ongoing.
- Conduct 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.
- Provide protocol specific training to study team, Investigators, and others.
- Support study team in issues resolution, study close-out, audit responses, inspection readiness, etc.
- 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.
- Interact with Data Monitoring Committees (DMCs) and steering committees as required.
- Coordinate 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:

EDUCATION/EXPERIENCE:

- M.D. degree required, sub specialty and certification is highly desirable.
- Prior vaccines clinical trials experience a plus.
- At least 5 years pharmaceutical industry

Projektdetails

  • Einsatzort:

    Pearl River, Vereinigte Staaten

  • Projektbeginn:

    asap

  • Projektdauer:

    Keine Angabe

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Synectics