TMF Document Coordinator I-India

The TMF Document Coordinator I plays a key support role in maintaining the Sponsor’s Trial Master File (TMF) throughout the duration of a clinical trial. The TMF Coordinator I 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.

More specifically, the TMF Document Coordinator I must:

• Review TMF records for completeness, accuracy, and quality prior to approval.

• Classify records and assign appropriate metadata based on record type.

• Identify quality issues, issue pre‑approval queries, and coordinate with submitters to ensure timely resolution.

• Participate in 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.

• College degree.

• Experience in clinical research within the biotechnology, pharmaceutical, or CRO industry.

• Intermediate proficiency in English.

• 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.

• 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.