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
Website: Cpl Life Sciences
- Posted: 15th June 2022
- Expires: 13th July 2022
