Clinical Documentation Specialist

Experience Dependent
29 Aug 2019
26 Sep 2019
Rhys Evans
Contract Type
Full Time
We are currently looking for a Clinical Documentation Specialist to join a leading ATMP company based in London. As the Clinical Documentation Specialist, you will be responsible for ensuring the quality of global Trial Master Files internally and externally for CRO studies and sponsors.


Your duties as the Clinical Documentation Specialist will be varied. However, the key duties and responsibilities are as follows:

1. You will plan, perform and follow up internal and external audits of paper and electronic TMFs to ensure compliance to quality standards, raising any compliance gaps.

2. As the Clinical Documentation Specialist, you will write controlled documentation and ensure all documentation is appropriately processed in the eTMF for ongoing review of their quality standards.

3. You will ensure all controlled paper documentation is archived and maintain an inventory to ensure submission and inspection readiness.

4. As the Clinical Documentation Specialist, you will be the point of contact for intra and inter business teams in the maintenance of TMFs and you will train staff on the regulatory requirements of the controlled documentation.


To be successful in your application to this exciting opportunity as the Clinical Documentation Specialist, we are looking to identify the following on your profile and history:

1. Relevant Life Sciences degree.

2. Proven industry experience in TMF document management, TMF audits and training staff on TMF regulatory requirements.

3. A working knowledge and practical experience with GCP regulatory requirements.

Key Words: Clinical Documentation | QA | Quality Assurance | TMF | Trial Master File | eTMF | Electronic Trial Master File | GCP | Good Clinical Practice | ATMP | Advanced Therapy Medicinal Products | Cell and Gene Therapy | CRO | Clinical Research Organisation | Auditing | Documentation

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.