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Associate Director Clinical Operations


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Company Overview: 

Meet is working with groundbreaking biopharmaceutical company that is seeking an Associate Director of Clinical Operations. They will be responsible for the operational direction as well as the supervision of clinical development programs which is includes but is not limited to timelines, budgets, and resources. This individual will have the responsibility of managing the internal Clinical Operations staff, as well as external contract organizations. They will also be responsible for formulating and executing the operational portions of the company’s clinical trial programs among other duties assigned.

Job Responsibilities:


  • Directs and oversees all clinical operation aspects of clinical trials including managing clinical operations personnel
  • Identifies clinical program/resource gaps and devise and implements solutions
  • Provide operational input in the development of Clinical Development Plans (CDP) including timelines, budget, and resource requirements
  • Assists in the development of Clinical Operations quality systems, including Standard Operating Procedures (SOPs), document management, Clinical Operations personnel training, and quality control processes




Skills Required:


  • Strong clinical operations experience with thorough understanding of cross functional clinical processes including clinical supply, data management, biostatistics, and medical writing


  • Knowledge in Good Clinical Practices and ICH Guideline and the application to the conduct of clinical trials


  • Function management experience


  • Strong analytical and strategic planning skills
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