About The Position

Syneos Health is hiring a Trial Committee Manager for a six-month contract. Working under limited guidance and mentorship from a Manager, MCAM, or designee, the role serves as a functional lead on clinical trial committee projects and may lead standalone MCAM projects. The manager collaborates with internal functional groups, service providers, investigative sites, and customers to deliver MCAM-scoped services in accordance with objectives, quality standards, timelines, and budgets. The position develops and maintains project-specific committee charters and event/endpoint adjudication plans, coordinates committee workspaces and adjudication platforms, manages service providers and requests for additional adjudicator data, and works with Clinical Data Sciences, Medical, and Safety teams to identify potentially unreported events or endpoints. It also supports meeting and project planning, prepares event/endpoint narratives, reports status and delivery risks, maintains project documentation and Trial Master File records, manages scope, and participates in audits and inspections. The manager oversees project-assigned MCAM team members and trains and mentors Committee Specialists. The role is described as remote/hybrid. The stated salary range is $70,100 to $145,000. Benefits may include medical, dental, and vision coverage; a company 401(k) match; eligibility to participate in an Employee Stock Purchase Plan; potential commissions or bonuses based on company and individual performance; flexible paid time off and sick time; and a company car or car allowance.

Requirements

  • Independent trial committee management experience is required.

Responsibilities

  • Serve as an MCAM functional lead representing the team on small to large clinical trial committee projects or programs.
  • Serve as Project Lead for MCAM standalone projects when assigned.
  • Collaborate with functional groups, service providers, investigative sites, and customers.
  • Attend Trusted Process or customer meetings to discuss strategy for trial committee requirements.
  • Represent MCAM at internal and customer meetings, address MCAM agenda topics, and provide status reports.
  • Manage MCAM-scoped services to meet objectives, quality standards, timelines, and budget.
  • Develop and maintain project-specific Committee Charters and Event/Endpoint Adjudication Plans in accordance with SOPs and WIs.
  • Develop specifications for committee collaborative workspaces, electronic adjudication platforms, and outcome forms.
  • Manage and attend service-provider meetings and set up purchase orders for providers supporting MCAM services.
  • Manage adjudicators’ requests for additional data.
  • Work with Clinical Data Sciences, Medical, and Safety teams to identify potential unreported clinical endpoints or events that may require adjudication.
  • Write event/endpoint narratives for adjudication packages or distribution to committee members.
  • Develop committee meeting timelines and coordinate across functional areas to ensure deliverables are met.
  • Provide timely status updates to internal and customer project teams, identify delivery risks such as timeline delays, and serve as a central point of contact for MCAM-related project issues.
  • Seek support from the Line Manager or MCAM subject matter experts as needed.
  • Contribute to functional project plans to align them with the Committee Charter and Event/Endpoint Adjudication Plan.
  • Maintain MCAM project documentation and ensure required documents are filed completely and accurately in the Trial Master File.
  • Manage MCAM scope, identify out-of-scope activities and overburn, and perform revenue recognition if delegated by the project lead.
  • Participate in customer, internal, or agency audits and inspections as required.
  • Oversee MCAM members assigned to the same project.
  • Train and mentor Committee Specialists.

Benefits

  • Medical, dental, and vision health benefits.
  • Company match on 401(k).
  • Eligibility to participate in the Employee Stock Purchase Plan.
  • Eligibility to earn commissions or bonuses based on company and individual performance.
  • Flexible paid time off and sick time, subject to applicable location requirements.
  • A company car or car allowance may be included.
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