165.00 Dollar US$ Clinician Medical Monitor (CMM) (Pearl River, NY) Pearl River

Our client, a Global Pharmaceutical Company, is seeking a Vaccines 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.

Responsibilities:

The Clinician Medical Monitor is accountable for safety across the study
Ensure development of and adherence to the Safety Review Plan (SRP)
Consistent with the SRP, the Clinician Medical Monitor will perform and document regular review of individual subject safety data, and perform review of cumulative safety data with the Safety Risk Lead
As appropriate, the Clinical Medical Monitor may delegate these responsibilities to the Study Clinician Scientist identified in the SRP
The Clinician Medical Monitor will monitor study safety issues and provide input to SAEs reports
Participate in the Safety Review Team (SRT) to evaluate medical benefits/risks to support targeted clinical indications
The Clinician Medical Monitor will 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 or those posed by the SRT, DMC or other individuals or bodies involved with the study
The Clinician Medical Monitor will 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 the stated objectives
The Clinical Medical Monitor will assure that clinical trial objectives fit with the clinical program strategy
Ensure that documents (protocol, ICD, etc) meet regulatory requirements and company policy and has been reviewed by IRB/IECs
Provide medical input into country feasibility Support Study Team
The Clinician Medical Monitor will 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 oversee work of protocol/study team)
Develop and maintain peer to peer relationships with healthcare professionals at clinical trial sites (in collaboration with RMMs when assigned to a study)
Contribute to CRO/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 (e.g. lab specifications)
Work with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., 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
The Clinician Medical Monitor is 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 PhRMA results database
Provides protocol specific training to study team, Investigators, CRA, and others
Interact with healthcare professionals at sites (leveraging the RMMs when assigned) during the conduct of the study to enable quality, compliance and patient safety at the trial, site and patient level
The Clinician Medical Monitor will 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
The Clinician Medical Monitor will monitor investigator compliance with protocol and regulatory requirements
Support study team in issues resolution, study closeout, audit responses, inspection readiness, etc.
Qualifications:

MUST have at least 5 years pharmaceutical industry experience and be a MD
Prior vaccines clinical trials experience a plus
Education Requirements:

MD (a medical degree from an accredited institution - MUST have passed the boards)
Do not need to hold a current medical license but it is preferred
Prefer VCR Clinician
Benefits: Eligible for Atrium Care Package | Compensation: $165 +/Hour DOE

APPLY NOW: https://www.atriumstaff.com/job-seekers/job-details/?positionId=15870

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