Jobs · Manufacturing

Site Operations Manager- Contractor

Science 37 · United States · 2 wk ago
RemoteRemoteManufacturingContract

About the role

The Site Operations Manager I is a member of the Clinical Operations department accountable for on-time and on-budget delivery of clinical studies using the highest quality standards. The Site Operations Manager I will have a broad therapeutic knowledge leading the multifunctional study management team within a matrix environment. The study management team is collectively responsible for planning, solutioning, recruiting, executing, and close-out of clinical studies, within the scope of the client agreement. In doing so, the Site Operations Manager I will oversee all operational aspects of clinical trials according to and in compliance with corporate and project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonisation (ICH) guidelines and other applicable federal (FDA) and state regulations, to achieve established goals within timelines and budget. The Site Operations Manager I is the single point of contact to client study teams working with internal and external stakeholders. This individual is accountable for the delivery of the project objectives on-time and on-budget and is responsible for end-to-end execution of clinical trials to ensure effective and timely internal and external communication of study progress, issues, and plans for resolution. The Site Operations Manager I is also responsible for efficient resourcing and financial management of studies under their supervision.

Responsibilities

  • Develops a project management plan in conjunction with the appropriate cross-functional teams, outlining planning, execution, and closeout milestones in addition to communication and contingency plans
  • Leads multi-disciplinary Study Management Team
  • End-to-end management of clinical studies to ensure appropriate resourcing and timely and high-quality delivery by all functional areas.
  • Ability to identify and organize resources and services needed to accomplish tasks, sets objectives, plans for

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