eTMF coordinator

15 hours, 31 minutes ago
Full-time
Senior
Project and Program Management
Excelya

Excelya

Excelya is a global CRO offering full-service, FSP, and Resourcing solutions to Biotech, Pharma, and Medical Device companies, prioritizing people-first healthcare advancements.

Professional Services
251-1K
Founded 2014

Description

  • Manage the end-to-end lifecycle of eTMFs, including setup, maintenance, and close-out for clinical studies.
  • Perform regular quality control checks to ensure document completeness, accuracy, and regulatory compliance.
  • Monitor TMF metrics and KPIs to support inspection readiness.
  • Review and approve TMF management plans for internal teams and CROs.
  • Act as a Subject Matter Expert by providing guidance and training on eTMF best practices.
  • Develop, update, and maintain SOPs, templates, and processes related to TMF management.
  • Serve as the main point of contact for eTMF-related queries, audits, and inspections.
  • Ensure the eTMF system complies with validation and regulatory requirements.
  • Manage user access, system updates, and migrations, and assess the impact of new system releases.
  • Collaborate with IT teams to resolve system issues and support continuous improvement.

Requirements

  • Bachelor’s or Master’s degree in Health Sciences, Life Sciences, or a related field.
  • Strong experience in clinical trial documentation management.
  • Hands-on experience with Veeva Vault TMF (mandatory).
  • Strong understanding of the DIA TMF Reference Model.
  • Experience with TMF metrics, KPIs, and dashboards.
  • Strong knowledge of ICH/GCP guidelines and regulatory requirements.
  • Understanding of the clinical trial documentation lifecycle.
  • Knowledge of cross-functional stakeholders such as Clinical, QA, PV, and Biometry teams.
  • Fluent English, both written and spoken.

Benefits

  • Opportunity to join a growing health company with around 900 employees.
  • Exposure to diverse projects through a one-stop provider model offering full-service, functional service provider, and consulting work.
  • Collaboration with preeminent experts in a science- and teamwork-driven environment.
  • A company mission focused on improving scientific, operational, and human knowledge to enhance the patient journey.
  • An environment that values natural talents and encourages professional growth.
  • A culture that pushes boundaries with audacity and supports personal potential.

Interested in this position?

Apply directly on the company website

Apply Now

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