Trial Committee Manager - Remote/Hybrid (Independent Trial Committee Mgmt Experience Required)
Job ResponsibilitiesWorking under the limited guidance and mentorship of a Manager, MCAM or above (Line Manager) or designee:
- 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.
At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.
Salary Range:
$70,100.00 - $145,000.00
The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.
