Associate I, TMF Operations Specialist

hace 1 semana

Xico, México Worldwide Clinical Trials A tiempo completo
About the Role

We are seeking a highly skilled and detail-oriented Associate I, TMF Operations Specialist to join our team at Worldwide Clinical Trials. As a key member of our operations team, you will play a critical role in ensuring the quality and integrity of our clinical trial documents.

Key Responsibilities
  • Process Trial Master File (TMF) documents for multiple studies in both electronic and hard copy formats
  • Prepare periodic TMF Quality Control checklists for review by the project team
  • Perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, sponsor, and industry best practices
  • Work with various electronic document management and electronic TMF systems to review, classify, and process essential documents
  • Communicate directly with project team members to assess project needs relevant to the TMF
  • Escalate any TMF Quality issues in a timely manner to relevant parties
  • Prepare and transmit TMF and other critical documents to the sponsor in accordance with relevant instructions
Requirements
  • Possess data collection, indexing, and editing skills, including the ability to adhere to standardized document naming conventions
  • Possess excellent written and verbal communication skills to clearly and concisely present information
  • Work independently and with teams, executing tasks under general direction and seeking assistance as needed
  • Display strong interpersonal skills in a fast-paced, deadline-oriented, rapidly changing environment
  • Exercise sound judgment and ability to identify decisions requiring supervisory approval
  • Handle multiple, highly detailed tasks with exceptional accuracy
  • Demonstrate strong planning and organizational skills
  • Demonstrate proficiency in Microsoft Word and Excel
  • Develop proficiency in the use of an electronic document repository or eTMF
  • Understand and adhere to corresponding Worldwide and sponsor standard operating procedures
  • General understanding of clinical research principles and processes
Preferred Qualifications
  • University degree preferred (Life Science desirable)
  • Up to 1 year of relevant experience
  • Knowledge of working within a highly regulated industry (desirable)
About Us

At Worldwide Clinical Trials, we balance fun with the serious business of changing lives. We have a values-driven culture that is built from the ground up. We empower our team members to treat every clinical trial like a patient's life depends on it - because it does. Our leaders are in the trenches with you - committed to advancing science and moving mountains for our customers.

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