Klinera is inviting applications for the position of eTMF Specialist at its Mumbai (Vidyavihar) office. This is an excellent opportunity for professionals with 2โ3 years of experience in electronic Trial Master File (eTMF) management and hands-on expertise in Veeva Vault eTMF.
If you have experience managing clinical trial documentation, TMF quality reviews, audit readiness, metadata compliance, and ICH-GCP documentation standards, this opportunity offers the chance to work in a dynamic clinical research environment with a 5-day workweek.
Job Details
| Particular | Details |
|---|---|
| Company | Klinera |
| Job Title | eTMF Specialist |
| Location | Vidyavihar, Mumbai |
| Experience | 2โ3 Years |
| Employment Type | Full-Time |
| Work Mode | Work From Office |
| Working Days | 5 Days a Week |
| Department | Clinical Operations / TMF Management |
Key Responsibilities
As an eTMF Specialist, you will be responsible for maintaining electronic Trial Master Files and ensuring regulatory compliance throughout clinical studies.
Responsibilities include:
- Manage setup and maintenance of electronic Trial Master Files (eTMF)
- Maintain Trial, Country and Site level documentation
- Coordinate with Clinical Team Leaders, CRAs, CTAs, Project Managers and QA teams
- Map sponsor TMF Index with sponsor-specific eTMF Index where applicable
- Add, modify and maintain approved TMF artefacts
- Perform visual quality checks on uploaded electronic documents
- Conduct Audit Ready Checks for every uploaded document
- Identify missing documents and initiate “What’s Missing” activities
- Track missing, incomplete or inaccurate TMF artefacts
- Maintain complete TMF according to study milestones
- Ensure metadata compliance
- Process final essential documents throughout all study phases
- Support client audits and regulatory inspections
- Prepare TMF status reports for study teams
- Identify TMF quality trends and escalate observations
- Participate in study meetings and cross-functional discussions
- Perform additional TMF-related operational activities
Required Qualifications
Candidates should possess any of the following:
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc Life Sciences
- M.Sc Life Sciences
- Biotechnology
- Microbiology
- Clinical Research
- Biomedical Sciences
- Any relevant Life Sciences degree
Required Skills
- Mandatory: Veeva Vault eTMF experience
- Electronic Trial Master File management
- Trial Master File documentation
- ICH-GCP Guidelines
- Clinical Trial Documentation
- Metadata Management
- Audit Readiness
- Quality Review
- Document Control
- Clinical Operations
- Sponsor SOP Compliance
- Inspection Readiness
- Communication and coordination skills
- Attention to detail
Why Join Klinera?
- Work with global clinical trials
- Exposure to Veeva Vault eTMF
- Opportunity to support regulatory inspections
- Structured 5-day working schedule
- Collaborative clinical operations environment
- Career growth in Trial Master File management
How to Apply
Interested candidates can share their updated resume to:
Email: prachi.sonawane@klinera.com
Apply as early as possible since hiring is currently underway.