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Senior Associate II, TMF Operations Specialist
hace 2 meses
We are seeking a highly skilled Senior Associate II to join our TMF Operations team at Worldwide Clinical Trials. As a key member of our global team, you will be responsible for maintaining Trial Master Files inspection readiness in compliance with relevant Standard Operating Procedures, ALCOA principles, country regulations, and industry best practices.
Key Responsibilities- Support the setup and coordination of Trial Master Files, ensuring seamless communication between Project Teams and eTMF administrators.
- Maintain accurate and up-to-date Sciforma resources and tasks.
- Collaborate with multiple Project Team members to assess project needs relevant to the TMF.
- Provide Subject Matter Expert (SME) support for Project Teams and Sponsors related to TMF.
- Oversee the Quality Control process and ensure the Regulatory Management Center (RMC) is on track, compliant with timelines.
- Strong data collection, indexing, and editing skills, including adherence to standardized document naming conventions.
- Excellent written and verbal communication skills to present information clearly and concisely to internal and external parties.
- Ability to work independently and with teams (internal and external) and handle multiple, highly detailed tasks with exceptional accuracy.
- Strong planning and organizational skills.
- Proficiency in Microsoft Word and Excel.
A University Degree is preferred, with a Life Science background being desirable. A combination of education and 1-3 years of relevant experience is required.
