Coordonnateur(trice) de la documentation TMF II/TMF Document Coordinator II

Indero•Montreal, QC

5d•Remote

About The Position

The TMF Document Coordinator II plays a key support role in maintaining the Sponsor’s Trial Master File (TMF) throughout the duration of a clinical trial. The TMF Coordinator II reviews and processes TMF records through quality control workflows to ensure they meet required quality, compliance, and regulatory standards before being approved into the TMF, following study-specific guidelines, SOPs, and ICH‑GCP requirements. In addition to performing all core TMF review and quality control activities, the TMF Document Coordinator II independently leads TMF activities for Investigator‑Initiated Studies (IIS) and Sponsored Studies of limited scale and complexity.

Requirements

College degree.
At least 1 year experience in clinical research within the biotechnology, pharmaceutical, or CRO industry.
Advanced proficiency in English.
Knowledge of the TMF Reference Model and eTMF technologies.
Computer skills and proficiency in Microsoft Word and Excel.
Good organizational skills with the ability to manage multiple assignments.
High attention to detail and accuracy.
Good communication skills.
Ability to meet established timelines, expectations, and objectives.
Adaptable and comfortable working in a multitasking environment.
Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

Responsibilities

Review TMF records for completeness, accuracy, and quality prior to approval in the TMF.
Classify records and assign appropriate metadata based on record type in compliance with sponsor requirements, internal tools/procedures, and global regulatory standard.
Identify quality issues, issue pre‑approval queries, and coordinate with submitters to ensure timely resolution.
Participate in or perform TMF quality reviews and address assigned findings promptly.
Assist in maintaining study milestones and expected document lists.
Support the TMF Project Lead in generating monthly TMF metrics and related reports.
Attend internal TMF Focus meetings to provide updates on TMF status, issues, and outstanding queries.
Collaborate with project team members to resolve issues impacting TMF records. Escalate recurrent or unaddressed issues to TMF Project Lead, as required.
Lead TMF activities for Investigator‑Initiated Studies (IIS) and Sponsored Studies of limited scale and complexity, including additional responsibilities such as:
Oversee the eTMF from study start to study closeout.
Develop and maintain the TMF Management Plan and TMF Index.
Create and maintain study milestones and expected document lists.
Prepare TMF performance metrics; monitor trends and escalate issues as needed.
Generate reports to support identification of missing TMF records.
Coordinate TMF activities and deliverables (i.e., periodic completeness and quality reviews)
Lead internal TMF Focus Meetings.
Manage TMF closeout activities in collaboration with cross-functional teams.
May contribute to process improvement initiatives.
May assist with administrative activities related to the management of computerized systems (e.g., user access administration and periodic reviews).
The TMF Document Coordinator II may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.