[Hiring] TMF Document Coordinator I @Indero

Role Description

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.

• 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.

Qualifications

• 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.

Benefits

• Flexible work schedule.
• Permanent full-time position.
• Ongoing learning and development.

Company Description

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 opportunities.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in India.