Senior Associate I, TMF Operations Specialist
hace 3 semanas
We are seeking a highly skilled Senior Associate I, 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:- Perform RMC Lead Activities for 1-3 Studies
- Support TMF set-up, coordinate 'Requests for Sites to be added in eTMF' between Project Teams (PT) and eTMF administrators; review eTMF access and coordinate updates, as necessary
- Maintain Sciforma resources and tasks up to date
- Communicate directly with multiple Project Team members to assess project needs relevant to the TMF
- Provide Subject Matter Expert (SME) support for Project Teams and Sponsor related to TMF
- Oversee the QC process and make sure the RMC is on track (compliant with timelines and documentation) and follow up on non-compliance accordingly
- 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 year of relevant experience
- Knowledge of working within a highly regulated industry (desirable)
We are committed to creating a diverse and inclusive environment that promotes collaboration and creativity. If you are a motivated and detail-oriented individual who is passionate about clinical trials and document management, we encourage you to apply for this exciting opportunity.
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