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.
Apply:
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
Website: CK Group
- Posted: 31st August 2023
- Expires: 28th September 2023
