We currently have an exciting opportunity available for a Clinical Compliance Study Lead to join a growing biotechnology company based in the Oxfordshire area.
As the Clinical Compliance Study Lead you will be responsible for providing GCP guidance throughout all phases of a clinical study, inclusive of TMF Operations to assess compliance with relevant regulations and applicable policies and procedures.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Clinical Compliance Study Lead will be varied however the key duties and responsibilities are as follows:
1. Serves as the Clinical Compliance Study Conduct Team Representative and provides GCP guidance throughout all phases of the study.
2. Responsible for study-specific management of Program and/or Trial Master Files.
3. Responsible for quality review of filed documentation in the Program and/or Trial Master Files.
4. Provide advice concerning GCP regulatory requirements.
5. Review Clinical Documentation for consistency, quality, and regulatory compliance.
6. Support the advancement / development of the Clinical Quality and Compliance Program. Support the mentorship of clinical compliance personnel.
To be successful in your application to this exciting opportunity as the Clinical Compliance Study Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a life sciences focussed discipline. In addition, you will have experience working for a sponsor or full service CRO in a GCP capacity. A RQAP-GCP, RQAP-GLP or ASQ-CQA is highly desirable.
2. Proven industry experience with TMF operations, gained in a clinical quality and compliance role.
3. Desirable: previous experience as a CRA, supporting GCP, GCLP, GLP audits, or experience preparing for and participating in regulatory inspections.
Key Words: Clinical Compliance | Clinical Quality | TMF Operations | Study Lead
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.
You must be eligible to work in the UK. Learn more
- Agency: Hyper Recruitment Solutions
- Contact: Eve Hegarty
- Phone: 0131 202 9700
- Reference: J5634487
Website: Hyper Recruitment Solutions
- Posted: 17th February 2021
- Expires: 17th March 2021