Associate II, TMF Operations Specialist
hace 1 semana
We are seeking a highly organized and detail-oriented Associate II, TMF Operations to join our team at Worldwide Clinical Trials. As a key member of our operations team, you will be responsible for the processing, maintaining, and archiving of essential documents in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
Key Responsibilities- Fulfill 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.
- 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.
- University Degree preferred (Life Science desirable).
- Up to 1-2 years of relevant experience.
- Knowledge of working within a highly regulated industry (desirable).
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