Senior Associate I, TMF Operations Specialist

hace 4 semanas


Xico, México Worldwide Clinical Trials A tiempo completo

**About the Role**

Worldwide Clinical Trials is seeking a highly skilled Senior Associate I to join our TMF Operations team. As a key member of our team, you will be responsible for processing, maintaining, and archiving 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.

**Requirements**

  • 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.

**What We Offer**

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.



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