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Trial Committee Manager – Independent Trial Committee Management Experience Required
Syneos Health. Serve as a functional lead representing the MCAM team on clinical trial committee projects and programs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Independent Trial Committee Management (MCAM) with a strong ability to lead projects, develop Committee Charters, and manage project documentation in compliance with SOPs and WIs. Proven skills in collaboration with cross-functional teams and effective communication of project status and risks.
Highest-signal resume keywords
Independent Trial Committee ManagementProject ManagementCommittee Charter DevelopmentEvent/Endpoint Adjudication PlansTrial Master File (TMF) Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project ManagementCommittee Charter DevelopmentEvent/Endpoint Adjudication PlansTrial Master File (TMF) ManagementData ManagementRisk IdentificationService Provider ManagementPurchase Order ManagementEvent/Endpoint Narrative WritingProject Timeline Development
Soft Skills
CollaborationMentoringCommunicationLeadershipProblem-Solving
Tools & Technologies
Electronic Adjudication PlatformsCollaborative Workspaces
Industry Keywords
Clinical Trial ManagementSOPsWIsAuditsInspections
About the role
Key responsibilities & impact- Serve as a functional lead representing the MCAM team on clinical trial committee projects and programs
- Serve as Project Lead on MCAM stand-alone projects when applicable
- Collaborate with functional groups, service providers, investigative sites, and customers
- Attend Trusted Process, customer, internal, and agency meetings as an MCAM representative
- Discuss trial committee strategy and address MCAM-related agenda topics
- Manage MCAM-scoped services to meet objectives with quality, timeliness, and budget adherence
- Develop and maintain project-specific Committee Charters and Event/Endpoint Adjudication Plans
- Set up committee collaborative workspaces, electronic adjudication platforms, and outcome forms
- Manage service-provider meetings and purchase orders
- Manage adjudicator requests for additional data
- Coordinate with Clinical Data Sciences, Medical, and Safety teams regarding potential unreported endpoints or events
- Write event/endpoint narratives for adjudication packages
- Develop committee meeting timelines and coordinate deliverables across functions
- Provide status updates and escalate delivery risks and project issues
- Contribute to project plans and align them with committee documentation
- Maintain MCAM project documentation and ensure complete, accurate TMF filing
- Manage MCAM scope, out-of-scope activities, overburn, and delegated revenue recognition
- Participate in audits and inspections
- Oversee MCAM team members and mentor Committee Specialists
Requirements
What you’ll need- Independent Trial Committee Management (MCAM) experience required
- Ability to serve as a functional lead on small to large-sized projects or programs with clinical trial committees
- Experience interacting and collaborating with functional groups, service providers, investigative sites, and customers
- Knowledge of clinical trial committee requirements and strategy
- Ability to develop and maintain Committee Charters and Event/Endpoint Adjudication Plans in accordance with SOPs and WIs
- Ability to develop specifications for collaborative workspaces, electronic adjudication platforms, and outcome forms
- Experience managing service providers and setting up purchase orders
- Ability to manage requests for additional data from adjudicators
- Ability to liaise with Clinical Data Sciences, Medical, and Safety teams
- Ability to write event/endpoint narratives for adjudication packages
- Ability to develop project timelines and coordinate deliverables across functional areas
- Ability to provide status updates, identify delivery risks, and manage project issues
- Ability to maintain project documentation and file documentation accurately in the Trial Master File (TMF)
- Ability to manage MCAM scope, out-of-scope activities, overburn, and revenue recognition when delegated
- Ability to participate in audits and inspections
- Ability to oversee MCAM team members
- Ability to train and mentor Committee Specialists
- Equivalent experience, skills, and/or education will also be considered
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition and total rewards program
- Inclusive culture
- Company car or car allowance
- Medical, Dental and Vision health benefits
- Company match 401k
- Eligibility to participate in Employee Stock Purchase Plan
- Eligibility to earn commissions/bonus based on company and individual performance
- Flexible paid time off (PTO)
- Sick time