An excellent opportunity for a Senior Clinical Auditor for Medical Device trials with a well established global CRO. The role will be based at their offices in either central Germany or western Switzerland.
As Senior Clinical Auditor, you will play a leading role in the development and maintenance of the global audit strategy and QA function as well as organizing and participating in both external and internal audits and ensuring readiness for inspections from clients and regulatory authorities.
Other duties will include training and supervising junior auditors, QA review of SOPs and the preparation of quality report documentation.
BSc in a relevant technical subject
- Proven experience of clinical trial auditing for Medical Device studies of investigator sites, TMFs, vendors, databases etc
- A strong understanding of ICH GCP requirements and the clinical development process
- Experience of hosting audits by regulatory authorities
- Able to travel when required
- Excellent communication and persuasive skills
For more information or to apply for this Senior Clinical Auditor position, please contact Jim Gleeson at CK Clinical on +44 (0)1438 870027 or email firstname.lastname@example.org. Entitlement to work in the EEA is essential. Please quote reference CL21362 in all correspondence.