Are you passionate about clinical research and documentation management? Here’s your chance to advance your career as a Senior TMF Associate in Mumbai with a fully remote working option.
In this role, you’ll manage electronic Trial Master Files (eTMF), maintain audit readiness, and support clinical operations in compliance with ICH-GCP and regulatory standards.
This position is perfect for professionals with 3–6 years of experience in clinical research who excel in documentation, compliance, and quality processes.
Job Overview
As a Senior TMF Associate, you will oversee document classification, ARC review, and deletion within the eTMF system. You will collaborate with global study teams to ensure timely and accurate documentation for ongoing and completed clinical trials.
Key Responsibilities
- Manage document classification under Smart Inbox and ARC review.
- Perform Audit Ready Checks on all uploaded eTMF documents.
- Conduct visual quality checks for image clarity and data accuracy.
- Ensure continuous audit readiness in compliance with GCP and ICH guidelines.
- Track and process essential artifacts throughout study phases.
- Identify operational issues and implement corrective actions.
- Prepare TMF for sponsor or QA audits, and address audit findings.
- Participate in business improvement initiatives for quality and productivity.
- Train and mentor team members when required.
- Collaborate with cross-functional teams to enhance client satisfaction.
Required Qualifications
- Bachelor’s Degree in Life Sciences or Business discipline.
- 3–6 years of experience in a clinical research environment.
- In-depth understanding of GCP, ICH guidelines, and regulatory documentation.
- Proficiency in Microsoft Office, Adobe Acrobat, and web-based clinical systems.
- Strong communication and interpersonal skills.
Preferred Qualifications
- Master’s degree in Life Sciences or related discipline.
- Experience with clinical electronic systems (eTMF, CTMS, or EDC).
- Previous exposure to audit and document management systems.
Work Environment
- Remote-based position (Mumbai location preferred).
- Minimal travel (less than 10%) for client or sponsor meetings.
Why Join
- Work remotely with a leading global clinical research organization.
- Gain exposure to international studies and regulatory compliance.
- Be part of a team that values quality, innovation, and continuous learning.
How to Apply
