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
Website: Cpl Life Sciences
- Posted: 8th June 2022
- Expires: 6th July 2022
