The demand for skilled professionals in clinical trials documentation and electronic Trial Master File (eTMF) management continues to rise as pharmaceutical and CRO organizations strengthen regulatory compliance and inspection readiness.
A new opportunity has opened for the role of eTMF Specialist in Bangalore, ideal for candidates with hands-on experience in clinical operations, TMF management, and Veeva Vault eTMF systems. This position offers a focused career path in clinical research documentation, ensuring quality oversight of essential trial records aligned with ICH-GCP and regulatory standards.
Key Responsibilities – eTMF Specialist
As an eTMF Specialist, you will play a critical role in maintaining the integrity and completeness of clinical trial documentation:
- Manage and maintain the electronic Trial Master File (eTMF) in compliance with regulatory guidelines.
- Perform TMF filing, indexing, and quality control (QC) checks for accuracy and completeness.
- Ensure documentation aligns with ICH-GCP, ALCOA+, and regulatory inspection readiness standards.
- Collaborate with Clinical Operations, Study Managers, and CRO teams for document reconciliation.
- Conduct periodic TMF health checks and completeness reviews.
- Support audit readiness and regulatory inspections by ensuring traceable documentation.
- Maintain workflows and lifecycle management within Veeva Vault eTMF.
- Identify process gaps and contribute to continuous improvement in TMF management.
Eligibility Criteria & Qualifications
Candidates applying for this clinical trials eTMF job in Bangalore should meet the following requirements:
- Experience: 1–4 years in Clinical Trials / Clinical Operations / TMF Management.
- Hands-on exposure to Trial Master File (TMF) processes.
- Working knowledge of Veeva Vault eTMF (preferred).
- Strong understanding of clinical research documentation standards.
- Familiarity with regulatory requirements, audit trails, and inspection readiness.
- Degree in Pharmacy, Life Sciences, Clinical Research, or related discipline.
Preferred Skills
- Document lifecycle management expertise.
- Knowledge of clinical study start-up, conduct, and close-out documentation.
- Attention to detail and strong organizational ability.
- Experience supporting global clinical trials teams.
- Understanding of regulatory compliance frameworks (FDA, EMA, ICH-GCP).
Salary & Benefits
- Estimated Salary Range: ₹4.5 LPA – ₹8 LPA (based on experience and TMF expertise).
- Opportunity to specialize in clinical documentation and regulatory compliance careers.
- Exposure to global clinical trial environments and digital TMF platforms.
- Career progression into Clinical Quality, Study Operations, or TMF Lead roles.
- Skill development in industry-leading systems like Veeva Vault.
Job Location
Bangalore, Karnataka, India
Interview Process
- Single Round – Face-to-Face Interview Only
How to Apply
Interested candidates can share their updated resume directly to:
Applicants with relevant clinical trials and eTMF experience are encouraged to apply at the earliest.
