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 positive clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement

📌 TMF Document Coordinator I-India (Pune)
🏢 Indero
📍 Pune