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Clinical Compliance Study Lead

Abingdon, OxfordshirePermanent
Experience Dependent
Job Reference: J5634487
Updated On: 17/02/2021
Status: Open to Applications
Hyper Recruitment Solutions
Sectors: Pharmaceutical, Biotechnology, Medical Device, Clinical Research Organisation, Contract Research Organisation, Contract Manufacturing Organisation, Contract Testing Organisation, Chemicals, Life Sciences, Cell & Gene Therapy, Bioprocessing

Skills: Clinical - Clinical Data Management, Clinical - CRA (perm), Clinical - CRA (contract), Quality Assurance - GCP, Quality Assurance - Clinical Supplies

Job Information

Role Overview

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.

Role Requirements

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.

Eve Hegarty
Your Recruitment ConsultantEve
DisclaimerHyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant 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 processionals and scientists. We look forward to helping you with your next career moves.