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Client Engagement (Sr Mgr to Dir)

Company: Planet Pharma
Location: Remote
Posted on: June 12, 2021

Job Description:

Job Description:

 The primary focus of the Associate Director, Client Engagement is to provide Quality Assurance support for decentralized clinical trial activities. This will include facilitation of quality issue investigation and CAPA development as well as identifying trends/signals from non-compliance data, and partnering with the business and sponsors to develop risk mitigation strategies. This individual will serve as the Quality interface with sponsors who have engaged decentralized clinical trial services, and as such may represent in sponsor audits or regulatory inspections.

  • Maintains currency with legislations, regulations, guidelines, Quality System, Sponsor requirements and inspection trends and signals related to decentralized clinical trials
  • Ensures the quality and integrity of the documentation of non-compliance by overseeing non-compliances in QMS related to DCT activities
  • Based on the risk, scope of impact and severity, determines the need and the level of actions required
  • Reviews the CAPA closure to ensure the documentation would sustain the scrutiny of an inspector or auditor
  • Ensures all compiled non-compliances build a Body of Knowledge on processes allow demonstration and assessment of efficiency and continuous improvement
  • Participates in the trending of and signal detection from non-compliances
  • Oversees the creation of Global CAPA on trends or signals identified
  • Communicates and discusses with functional units results of trending and signal detections of identified non-compliances and identifies Continuous Improvement Plans
  • Oversees that signals related to DCT activities are provided to auditors (Risk-based audits)
  • Participates in the review of the final draft of CDs to ensure (1) they are compliant with regulations/guidelines, regulatory agencies actual position and Labcorp Quality System and (2) they are consistent with the Body of Knowledge built with the review, trending and signal detection of CAPAs
  • Participates in regulatory inspections or sponsor audits regarding CAPAs, trends and continuous improvement projects
  • Contributes to process improvement across the Organization
  • Perform any required tasks as requested

Keywords: Planet Pharma, Eugene , Client Engagement (Sr Mgr to Dir), Other , Remote, Oregon

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