Associate II, TMF Operations - Europe - Remote
On-siteBelgrade, Central Serbia, Serbia or Zagreb, Zagreb, Croatia
Job Summary
Fulfil the "TMF Approver" and/or "TMF QC Reviewer" roles by processing, reviewing, and resolving rejected Trial Master File documents in electronic and hard copy formats. Prepare periodic Quality Control checklists and perform regular audits to ensure adherence to regulatory, ICH GCP, and industry best practices. Work with Electronic Document Management Systems to review, classify, and process essential documents while maintaining strict compliance with Standard Operating Procedures and country-specific regulations. Requires proficiency in Microsoft Word, Excel, and eTMF systems, along with 2-3 years of relevant TMF experience within the CRO or Pharma industry.
Required Qualifications
- 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
- Up to-2-3 years of relevant TMF experience within the CRO/Pharma industry
Desired Qualifications
- University Degree preferred (Life Science desirable)
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