• We use cookies to help make our website work. LEARN MORE

Senior Manager, Clinical Quality Assurance

Hatfield, Hertfordshire   •  Permanent, Full time

CK Group are recruiting for a Senior Manager, Clinical Quality Assurance to join a successful and expanding global pharmaceutical company, on a full time and permanent basis. The company are located in Hertfordshire, and are expecting an onsite commitment of 6-8 days per month (1-2 days per week).

Senior Manager, Clinical Quality Assurance Role:
As Senior Manager, Clinical Quality Assurance you will be responsible for quality oversight activities of Clinical Trials, Systems, & CROs (GCP related), for leading audits and health authority inspection management activities. You will support and manage cross-functional relationships with internal and external stakeholders and take the lead on Quality Assurance and clinical improvement initiatives. This is a high visibility position with great impact potential.

Key duties will include:

  • Proactively provide GCP QA support for clinical development activities to protect patient safety & wellbeing, maintain data integrity, and support operational excellence
  • Independently conduct Clinical Investigator Site Audits, GCP Document Audits (Clinical Study Reports and Trial Master Files and support Vendor/System audits
  • Author and manage Audit Plans and Audit reports
  • Facilitate ongoing quality improvement through communication of audit results, CAPAs and GCP guidance and consultation to clinical teams
  • Support health authority inspections
  • Review and provide input to clinical documentation (e.g., protocols, study reports, IBs, ICFs, etc.)
  • Compile and analyse audit metrics to communicate trends to business groups
  • Conduct GCP training sessions for business groups

Your Background:
As Senior Manager, Clinical Quality Assurance you will require:

  • A relevant BSc.
  • Strong Clinical Quality Assurance experience.
  • Experience with internal and external GCP audits and of hosting regulatory authority inspections.
  • An in-depth knowledge of international regulations and guidelines for the conduct of clinical trials.
  • Strong interpersonal skills & pro-acticve approach.
  • A willingness to learn and interest in Clinical QA.

It is essential that applicants hold entitlement to work in the UK. Please quote job reference 56013 in all correspondence.

You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Reference: 56013
  • Posted: 31st August 2023
  • Expires: 28th September 2023

CK Group

Share this job: