eTMF Specialist

at  MAC Clinical Research

Do you have clinical research experience and are looking for an opportunity to join a growing global CRO based in the UK? Come and join our Project Management team at MAC Clinical Research. We have an exciting new opportunity for an eTMF Specialist in line with our expanding portfolio.
We’re inviting candidates that thrive in a busy environment, who have an eye for the details and enjoy working within a hardworking and supportive team.

KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:

• At least 2 years’ industry experience in clinical trials, for example within a Site Management Organisation, Clinical Research Organisation, NHS clinical trials site or Pharmaceutical company (or equivalent).
• Knowledge of the DIA TMF Reference Model
• Experience managing eTMF documents utilising a reference model
• Able to plan and prioritise own workload, responding efficiently to requests from multiple project managers
• Ensuring clinical trial documentation is filed consistently with Electronic Trial Master File (eTMF) study specific specifications, and regulatory requirements.
• Oversee the integrity and quality of the eTMF, ensuring documents are filed in a timely manner and are easily accessible to stakeholders.

Please refer the Job description for details