Trial Committee Manager - Remote/Hybrid (Independent Trial Committee Mgmt Experience Required)

Job Responsibilities

• Serve as a functional lead as a representative for the MCAM team on small to large-sized projects or programs with clinical trial committees.
• May serve as a Project Lead in MCAM stand-alone projects.
• Interact and collaborate with other functional groups, service providers, investigative sites, and customers.
• Attend Trusted Process or customer meetings to discuss strategy for trial committee requirements.
• Attend internal and customer meetings as an MCAM representative, to address MCAM-related agenda topics, and provide status reports.
• Manage MCAM scoped services ensuring objectives are met, in good quality, on time and within budget including the following activities:
• Develop and maintain the project-specific Committee Charter and Event/Endpoint Adjudication Plan in accordance with Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Develop specifications required for setup of the committee's collaborative workspace and/or electronic adjudication platform and outcome forms.
• Manage and attend meetings with service providers. Setup purchase orders for service providers supporting MCAM services.
• Manage requests for additional data from adjudicators.
• Liaise with Clinical Data Sciences, Medical and Safety teams to identify any potential unreported clinical endpoints or events requiring adjudication.
• Write event/endpoint narratives for inclusion in adjudication package or distribution to other committee members.
• Develop timelines for committee meetings and liaise across functional areas to ensure deliverables are met.
• Provide regular and timely status updates to internal and customer project teams regarding MCAM scoped services, including risks to delivery such as timeline delays and serve as a central point of contact for MCAM-related project issues and solicit support from Line Manager or MCAM Subject Matter Expert(s), as needed.
• Contribute to relevant functional project plans to ensure alignment with the Committee Charter and Event/Endpoint Adjudication Plan.
• Ensure MCAM project documentation is maintained on an ongoing basis and ensure required documentation is filed completely and accurately in the Trial Master File (TMF).
• Responsible for management of MCAM scope, including identification of MCAM out of scope activities and overburn, revenue recognition (if delegated this task by project lead)
• Participate in customer, internal or agency audits and inspections, as required.
• Oversee the work performed by MCAM members assigned to the same project.
• Train and mentor Committee Specialists.