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Remote Clinical Research Program Manager

Company: PPD Development, LLC
Location: Wilmington
Posted on: September 16, 2021

Job Description:

Insight Global is looking for a Program Manager with a background in clinical research to sit fully remote in support of a large pharmaceutical client. The PM will be responsible for the following:

-Manages all clinical operational and quality aspects of allocated studies, of moderate to high complexity, in compliance with ICH GCP. In accordance to project specific requirements, may assume Lead CTM responsibilities on regional level, Clinical Study Manager (CSM) responsibilities or take on additional responsibilities; e.g. process improvements, manage complex programs, have wider management or project coordination responsibilities.

-Develops clinical tools (e.g. Monitoring Plan, Monitoring Guidelines) in conjunction with the Data Quality Plan. Contributes to the development of the Master Action Plan (MAP) for providing clinical related documents. Ensures timely set up, organization, content and quality of the relevant sections of the Trial Master File (local and central). May participate in the design and development of CRFs, CRF guidelines, patient informed consent templates and other protocol specific documents as required. Collaborates with the project manager to prepare, organize, and present at client meetings, including bid defense and hand-off meetings

-Bachelors Degree

-5+ years of experience specific to Program Management

-Clinical Research background (disease, vaccine, etc.)

Keywords: PPD Development, LLC, Wilmington , Remote Clinical Research Program Manager, Other , Wilmington, North Carolina

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