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TMF Associate

4 months, 1 week ago
Canada, United Kingdom, Hungary, Poland, Romania
Full-time
Junior
Operations Specialist
Project and Program Management
Apply Now
Alimentiv

Alimentiv

Alimentiv specializes in providing comprehensive clinical research services for gastrointestinal and liver diseases, leveraging a global site network, advanced medical imaging, and biomarker discovery to enhance patient recruitment and accelerate clini...

Professional Services
251-1K
Founded 1986
View All Jobs 23

Description

  • Serve as the primary TMF contact for assigned studies.
  • Manage TMF content and associated processes from study setup through transfer and archiving.
  • Ensure the TMF remains complete, contemporaneous, and inspection-ready throughout the study lifecycle.
  • Create and maintain study-specific TMF management documents, including file indices, expected document lists, and TMF management plans.
  • Develop and maintain study-specific work instructions as needed.
  • Perform quality control activities, periodic TMF inventories, and reconcile expected document lists based on study events and milestones.
  • Review, communicate, and escalate out-of-scope or incomplete documents to study teams.
  • Prioritize and resolve TMF help desk tickets, including triage when required.
  • Provide TMF training to internal and external stakeholders as needed.
  • File, retrieve, process, and review TMF documents in line with scanning best practices and ALCOA principles.
  • Complete routine administrative tasks and contribute to metrics, meetings, working groups, and departmental process improvement efforts.
  • Support internal systems and quality documents, and provide mentorship and training to junior staff.

Requirements

  • College diploma or degree.
  • 1-3 years of related experience or ongoing training.
  • Understanding of TMF organization, implementation, and archival.
  • Knowledge of relevant regulations and guidance related to TMFs.
  • Ability to apply ALCOA principles in TMF oversight.
  • Strong time management and problem-solving skills.
  • Ability to identify challenges and take initiative to find solutions.
  • Demonstrated computer literacy and proven working knowledge of Microsoft Office packages.
  • Potential to develop in the role.
  • Home-based work arrangement with ability to go into the office occasionally if needed.

Benefits

  • Remote, home-based work arrangement.
  • Occasional office access when needed.
  • Full-time, permanent employment.
  • A role with opportunities to support process improvement and internal system development.
  • Mentorship and training opportunities for junior staff, which may support team development and growth.

Interested in this position?

Apply directly on the company website

Apply Now

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