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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-2206-494814
  • Posted: 15th June 2022
  • Expires: 13th July 2022

Cpl Life Sciences

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