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Clinical Inspection Readiness

Middlesex   •  Negotiable  •  Contract/Temporary, Full time


Clinical Inspection Readiness

  • 12 month initial contract
  • 70,000-80,000
  • Uxbridge: Hybrid working available

CPL Life Sciences contract division are actively seeking a clinical trial expert who can support a specialist biopharma to ensure inspection readiness across a number of their clinical study programs.

Your key responsibilities will include:

  • Work in close partnership with the quality, clinical documentation and inspection management groups
  • Prepare for global inspections and ensure readiness across all sites and regions
  • Work collaboratively with the clinical trial management and leadership team to ensure inspective readiness at a study and site level
  • Provide updates to senior management on current process on inspection preparation
  • Review essential clinical documents and quality reports
  • Lead inspection readiness meetings including tracking inspection items
  • Provide guidance on regulations and compliance
  • Project manage trial and actual inspections throughout the process
  • Contribute to process improvement initiatives
  • Support internal teams and work cross-functionally to ensure inspection readiness
  • May require occasional travel to sites

Your tasks will include tracking; CTM readiness tracker, compliance, TMF metrics, quality conduct, monitoring, data entry, data queries

Previous experience and skills:

  • BSc degree in a relevant field
  • In depth knowledge of ICH/GCP
  • Strong working knowledge of both regulatory guidelines and regulatory bodies
  • Clinical data driven to planning and implementation
  • High attention to detail

If you have prior experience in Clinical Inspection Readiness then please apply here, or send your CV directly to sarah.phillips@cpl.com.

  • Agency: Cpl Life Sciences
  • Reference: JO-2206-494330
  • Posted: 8th June 2022
  • Expires: 6th July 2022

Cpl Life Sciences

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