Are you an experienced professional in clinical trial systems like eTMF and CTMS? A leading organization in the clinical research and medical device industry is hiring an eTMF & CTMS Specialist with 3โ4 years of experience.
This role is ideal for candidates who have hands-on exposure to clinical trial documentation, CTMS modules, and regulatory compliance (ICH-GCP) and are looking to grow in a CRO / clinical operations environment.
With increasing demand for digital clinical trial management systems, professionals skilled in eTMF (electronic Trial Master File) and CTMS (Clinical Trial Management System) are highly valuable in the industry.
๐ Key Responsibilities
- Work extensively with eTMF systems, ensuring proper document filing and indexing
- Manage and support CTMS modules, including:
- Site tracking
- Study milestones
- Payments and budgets
- Monitoring visit tracking
- Ensure ICH-GCP compliance and maintain audit-ready documentation
- Support inspection readiness (internal & regulatory audits)
- Collaborate with Clinical Operations, QA, and Data Management teams
- Maintain TMF quality, completeness, and timeliness (ALCOA+ principles)
๐ Qualifications & Eligibility
- Bachelorโs or Masterโs degree in:
- Life Sciences
- Pharmacy (B.Pharm / M.Pharm)
- Clinical Research or related field
- 3โ4 years of experience in:
- eTMF systems (Veeva Vault, etc.)
- CTMS platforms
- Clinical trial documentation
๐ก Preferred Skills
- Strong understanding of ICH-GCP guidelines (E6 R2/R3)
- Experience with TMF audit readiness and reconciliation
- Familiarity with clinical trial workflows & regulatory requirements
- Excellent coordination and communication skills
- Detail-oriented mindset with strong quality focus
๐ฏ Benefits of This Role
- Work in a high-demand clinical research domain
- Exposure to global clinical trial systems (eTMF & CTMS)
- Opportunity to collaborate with cross-functional teams
- Strong career growth in Clinical Operations / TMF / QA roles
- Build expertise in audit readiness & regulatory compliance
๐ฉ Application Process
Interested candidates can apply by sending their updated CV:
๐ง Email: rahulkumar.cr@merillife.com
๐ Subject Line Suggestion: Application for eTMF & CTMS Specialist โ Pharmabharat