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Clinical Study Manager

  • Contract
  • negotiable based on experience
  • Durham, North Carolina
  • Pharma & Biotech

Clinical Study Manager

A global pharmaceutical corporation based in RTP is seeking a Clinical Study Manager for a 12-month contract. This is an immediate opening and 100% office based, this individual will be responsible for operational study management of two clinical protocols.

The Clinical Study Manager will be responsible for: 1) managing third party vendors, including coordinating responses to third party vendor audits. 2) Preparing key reports on study progress and assists in management of aspects of clinical studies as delegated. 3) Tracking and assisting in the development of study specific timelines and including management and mitigation of deliverables. 4) Participation in vendor selection and contributes to RFP process and CIS process. 5) Lead meetings with CROs, vendors, and multi-functional teams on a day to day basis to ensure quality, on budget and timelines of deliverables. 6) Coordinates training of CRO staff, vendors, investigators, and study coordinators on study requirements and SOPs. 7) Assist in management of the Trial Master File process including setup, ongoing maintenance, accurate filing and administration of QC plan.

Location: Research Triangle Park, North Carolina

Duration: 12-month contract (long-term possibilities*)

Compensation: negotiable based on experience

Requirements:

  • Education: Minimum of a Bachelor's degree, preferably in life sciences.
  • Must have 8 years of Clinical Research/Operations experience and 5 years of study management experience.
  • Strong global project management experience is highly preferred.
  • Prior experience managing Phase III studies with multiple vendors is required.
  • Must have strong leadership skills and the ability to mentor junior staff including CRAs.
  • Respiratory therapeutic experience is desirable but not required.

Sthree US is acting as an Employment Business in relation to this vacancy.