Trial Committee Manager - Remote​/Hybrid; Independent Trial Committee Mgmt

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with.

AtSyneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance.

Working 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…