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Study Manager - Cell and Gene Therapy

Company: Pharmaron
Location: San Diego
Posted on: September 23, 2022

Job Description:

Position DescriptionThe Study Manager is responsible for oversight of in-vivo studies involving the testing of pharmaceutical compounds and medical devices. The Study Manager is a key member of the Absorption Systems Operations Team and functions as a liaison between the internal research scientists and account managers and our clients.Principal Duties and ResponsibilitiesThe Study Manager will perform, but not be limited to, the following duties and responsibilities:

  • Participate in the scheduling of studies to ensure appropriate resource management.
  • Ensure that all study supplies are ordered and received in a timely manner.
  • Lead kick-off meetings with the Study Directors and Research Associates to ensure proper study planning.
  • Primary point of contact for clients to provide scheduling details and in-study updates.
  • Work with the Account Managers and Study Directors to design studies that meet sponsors' needs in a scientifically sound and cost-effective manner.
  • Address customer requests for information promptly and accurately.
  • Follow internal processes for accurate record keeping of study designs, protocols, data, and reports.
  • Preparation of study data, protocols and reports as needed.
  • Perform other duties as directed by management.
    Requirements:Experience working with in vivo studies. Experience with typical and atypical dosing routes and sampling procedures. Must be proficient in Microsoft Office (Word, Excel, Outlook). Prior experience with preparation of Standard Operating Procedures (SOPs) and study protocols. Ability to perform duties and responsibilities with minimal supervision. Must be flexible to work varying schedules and hours as well as provide comprehensive, after-hours, and on-call coverage as needed.Experience with ocular studies and procedures is a plus. Experience with Provantis is a plus.Education:
    • Bachelor's degree with a minimum 5 years' or a Master's degree with experience in a lab setting is required.
    • AALAS certification, and/or additional related training are highly desired.
      • Experience in the technical writing of preclinical study protocols or reports will be considered a plus.

Keywords: Pharmaron, San Diego , Study Manager - Cell and Gene Therapy, Executive , San Diego, California

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