Associate II, TMF Operations - EMEA- Fixed term - Remote
Associate II, TMF Operations - EMEA- Fixed term - Remote
Posted 2 days ago
SENIORITY
Senior
About the role
- Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles as defined by the relevant Standard Operation Procedure(s) (SOP) and working practices.
- Process, review, and resolve rejected Trial Master File (TMF) documents, for complex studies or Sponsor portfolio of studies both in an electronic and hard copy format.
- Prepare periodic TMF Quality Control checklists for review by Project Team review.
- Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
- Work with a variety of Electronic Document Management and electronic TMF Systems to review, classify and process Essential Documents
- What you will bring to the role
- Possess data collection, indexing and editing skills, including ability to adhere to standardized document naming conventions
- Possess excellent written and verbal communication skills to clearly and concisely present information
- Display strong interpersonal skills in a fast-paced, deadline oriented, rapidly changing environment
- Handle multiple, highly detailed tasks with exceptional accuracy. Demonstrate strong planning and organizational skills
- Demonstrate proficiency in Microsoft Word and Excel
- Develop proficiency in use of an electronic document repository or eTMF. General understanding of clinical research principles and processes
- Your experience
- University Degree preferred (Life Science desirable)
- Up to 1-2 years of relevant TMF experience within the CRO/Pharma industry
Before you apply
Applying takes about a minute. These four things decide how fast it moves after that.
Your profile is current
It's what we read first. Occupations, seniority and locations matter more than a long history.
Two examples you can talk through
Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.
A number in mind
What you're on now and what would make you move. We negotiate better when we know both.
Your notice period
Employers plan around it, and it's the question that stalls offers most often.
Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.
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