Job Opportunity: TMF Classifier II (Hybrid)

Job Summary

Are you looking to advance your career in clinical document management? A leading Clinical Research Organization is seeking a detail-oriented and motivated TMF Classifier II to join our team in Bangalore. This hybrid role is perfect for professionals with 1–2 years of experience in clinical research, eTMF systems, and GCP compliance who are eager to make a significant impact in the clinical operations domain. You will play a critical role in maintaining the integrity, quality, and audit readiness of our clinical trial documentation.

Key Responsibilities

eTMF Management & Classification

• Manage electronic Trial Master Files (eTMF) across trial, country, and site levels.
• Perform precise document classification using Smart Inbox and ARC review workflows.
• Execute document lifecycle management, including appropriate deletion and archival processes.

Audit Readiness & Quality Control

• Conduct thorough visual quality checks to ensure the clarity, readability, and legibility of all documents.
• Perform routine Audit Ready Checks (ARC) to guarantee that documentation is complete, accurate, and compliant.
• Maintain the TMF in a state of continuous audit readiness for regulatory inspections.

Compliance & Documentation

• Ensure all processes align strictly with ICH-GCP guidelines, sponsor Standard Operating Procedures (SOPs), and internal company policies.
• Monitor and track essential clinical trial documentation throughout the study lifecycle.

Operational Collaboration & Improvement

• Proactively identify and resolve TMF-related operational issues.
• Collaborate effectively with global study teams, clinical operations personnel, and sponsors.
• Assist in the implementation of Corrective and Preventive Actions (CAPA) when necessary.
• Contribute to ongoing process improvement initiatives and support the training and mentoring of junior team members.

Requirements

Minimum Qualifications

• Bachelor’s degree in Life Sciences, Business, or a related field.
• 1–2 years of professional experience in clinical research and eTMF/document management.

Required Skills

• Solid understanding of ICH-GCP guidelines and clinical regulatory documentation requirements.
• Hands-on experience with eTMF systems (e.g., Veeva Vault).
• Proficiency in Microsoft Office Suite and Adobe Acrobat.
• Strong verbal and written communication skills with a focus on collaborative problem-solving.

Preferred Qualifications

• Master’s degree in Life Sciences or Business.
• Demonstrated experience working with global clinical trial electronic systems.

Benefits

We are committed to fostering a supportive work environment that promotes professional growth and work-life balance. Benefits include:

• Flexible Working: Hybrid work model to promote a better work-life balance.
• Global Exposure: Opportunity to work with international sponsors on diverse, high-impact clinical trials.
• Skill Development: Hands-on experience with industry-leading eTMF platforms and regulatory compliance processes.
• Career Progression: Clear pathways for growth within the clinical operations and regulatory domains.
• Competitive Compensation: We offer an attractive salary package (estimated ₹4.5 LPA – ₹7 LPA, commensurate with experience and organizational standards).

How to Apply

If you are passionate about clinical research and meet the requirements outlined above, we encourage you to submit your application. Please ensure your resume highlights your experience with eTMF systems and your knowledge of GCP guidelines.

• Role: TMF Classifier II
• Location: Bangalore (Hybrid)
• Application Deadline: March 25, 2026

To submit your application, please visit our official careers portal and search for the TMF Classifier II position using the job title or reference code. We look forward to reviewing your application!