Are you looking for an exciting opportunity in clinical research? We are hiring a TMF Associate II in Bangalore to manage electronic Trial Master Files (eTMF) and ensure compliance with regulatory standards. If you have 1-2 years of experience in clinical research and a strong understanding of GCP/ICH guidelines, this role is perfect for you!
About the Company
We are a leading global clinical research organization committed to advancing healthcare through innovative trials. Our team ensures high-quality document management, regulatory compliance, and audit readiness for clinical studies. Join us to contribute to life-changing research while growing your career in a dynamic environment.
Job Description & Responsibilities
As a TMF Associate II, you will:
✔ Manage eTMF documents (Trial, Country, and Site artifacts) in compliance with SOPs, GCP, and ICH guidelines.
✔ Perform document classification under Smart Inbox and ARC review.
✔ Ensure audit readiness by conducting visual quality checks and audit-ready checks on eTMF documents.
✔ Track essential study artifacts and resolve TMF-related operational issues.
✔ Support internal/client audits and implement corrective actions.
✔ Collaborate with cross-functional teams to ensure client satisfaction.
✔ Participate in process improvement initiatives to enhance efficiency.
✔ Provide training and mentoring as needed.
Qualifications & Experience
Minimum Requirements:
- Bachelor’s degree in Life Sciences/Business or related field.
- 1-2 years of experience in a clinical research environment.
- Strong knowledge of GCP, ICH guidelines, and regulatory document requirements.
- Proficiency in Microsoft Office, Adobe Acrobat, and web-based applications.
- Excellent interpersonal and organizational skills.
Preferred Qualifications:
- Master’s degree in Life Sciences/Business.
- Experience working with clinical electronic systems.
Work Environment
- Minimal travel (<10%) for client meetings or kick-offs.
- Hybrid/remote options may be available.
How to Apply
📌 Last Date to Apply: June 28, 2025 (Only 1 day left!)
