TMF Document Coordinator I

This is a fully remote position, open to applicants in India.

📋 Description

• Oversee the Sponsor’s Trial Master File (TMF) for the entire duration of a clinical trial.

• Examine and process TMF records through established quality control workflows.

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

• Categorize records and assign relevant metadata based on the type of record.

• Detect quality issues and raise pre-approval inquiries.

• Collaborate with submitters to ensure timely resolution of inquiries.

• Engage in TMF quality reviews and address findings assigned to you.

• Keep track of study milestones and maintain expected document lists.

• Assist the TMF Project Lead in generating monthly TMF metrics and related reports.

• Participate in internal TMF Focus meetings and provide updates on TMF status, issues, and pending inquiries.

• Work alongside project team members to resolve issues affecting TMF records.

⛳️ Requirements

• Bachelor's degree.

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

• Intermediate proficiency in English.

• Computer skills with proficiency in Microsoft Word and Excel.

• Strong organizational skills with the capacity to handle multiple assignments.

• Excellent attention to detail and accuracy.

• Ability to meet set timelines, expectations, and objectives.

• Flexible and comfortable working in a multitasking environment.

• Solid understanding of good clinical practices.

• Familiarity with applicable Health Canada and Food and Drug Administration (FDA) regulations and guidelines.

• Legally authorized to work in India.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time role.

• Continuous learning and development opportunities.

• Attractive prospects for advancement.

• Home-based work arrangement in India.