eTMF Specialist

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.

FOCUS OF THE JOB: 

• Providing support to the Project Management team in managing and overseeing the Electronic Trial Master File to ensure all documents related to clinical trials are properly organised, uploaded and stored in compliance with regulatory standards.

This role includes working from home and therefore we require you to have a set up at home that allows you to work comfortably. This includes an appropriate desk and chair (excl. IT equipment which we will provide), please confirm you are able to do this before proceeding with your application. 

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. 

• Health Insurance
• Free onsite parking
• 25 days annual leave (increasing in increments to 30 days after 6 years' service)
• Your birthday off work

Please email [email protected] should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.