eTMF CTMS Specialist Job in Ahmedabad at Meril Lifesciences for clinical research professionals with 3 to 4 years experience apply now
Advance Your Career in Clinical Trial Systems & Digital Research Operations
Professionals with experience in clinical trial documentation and systems like eTMF and CTMS have become highly valuable in today’s pharmaceutical and medical device industry. This opportunity offers a strong platform to enhance your expertise in clinical operations, compliance, and digital trial management systems within a reputed healthcare organization.
Company Overview
Meril Life Sciences Pvt Ltd is a well-established global medical device and healthcare solutions company headquartered in India. The organization is known for its innovation in medical technologies, including cardiovascular, orthopedic, and diagnostic solutions. With a strong focus on research and clinical excellence, Meril provides professionals with opportunities to work on global clinical trials and advanced healthcare systems.
Job Overview (Quick Details)
| Field | Details |
|---|---|
| Job Title | eTMF & CTMS Specialist |
| Company | Meril Life Sciences Pvt Ltd |
| Location | Ahmedabad, Gujarat |
| Department | Clinical Research / Clinical Operations |
| Employment Type | Full-Time |
| Experience Required | 3–4 Years |
| Qualification | B.Pharm, M.Pharm, Pharm.D, BSc, MSc (Life Sciences) |
| Salary | As per company norms |
| Job Mode | On-site |
Open Positions / Department Details
This role is part of the Clinical Research and Clinical Operations team, focusing on managing digital clinical trial systems such as eTMF (electronic Trial Master File) and CTMS (Clinical Trial Management System).
The selected candidate will play a critical role in maintaining compliant documentation, supporting audit readiness, and ensuring smooth clinical trial operations aligned with global regulatory standards.
Key Roles & Responsibilities
As an eTMF & CTMS Specialist, your key responsibilities will include:
- Manage eTMF systems, ensuring accurate filing, indexing, and organization of clinical trial documents
- Maintain document completeness and compliance with regulatory requirements
- Support CTMS modules including site tracking, milestones, payments, and monitoring activities
- Ensure adherence to ICH-GCP guidelines and maintain audit-ready documentation
- Assist in inspection readiness for internal and external audits
- Collaborate with Clinical Operations, Quality Assurance, and Data Management teams
- Monitor TMF quality, ensuring adherence to ALCOA+ principles (data integrity standards)
- Perform TMF reconciliation and resolve discrepancies
- Maintain timelines and ensure documentation is updated throughout the study lifecycle
Eligibility Criteria
Education
- Bachelor’s or Master’s degree in Pharmacy or Life Sciences
- Degree in Clinical Research or related field is also acceptable
Experience
- 3 to 4 years of hands-on experience in:
- eTMF systems (such as Veeva Vault)
- CTMS platforms
- Clinical trial documentation and compliance
Skills Required
Technical Skills:
- Strong understanding of eTMF structure and document management
- Experience with CTMS functionalities and modules
- Knowledge of clinical trial workflows and regulatory requirements
- Familiarity with TMF audit readiness and reconciliation processes
Regulatory Knowledge:
- Good understanding of ICH-GCP guidelines (E6 R2 / R3)
- Awareness of global regulatory requirements in clinical research
Soft Skills:
- Excellent coordination and communication abilities
- Strong attention to detail and quality focus
- Ability to manage multiple tasks and timelines efficiently
Salary & Benefits
- Salary: As per company norms
- Opportunity to work in a high-demand clinical research domain
- Exposure to global clinical trial systems and regulatory frameworks
- Career growth opportunities in Clinical Operations, QA, and TMF management
- Hands-on experience in audit readiness and compliance
Selection Process
The hiring process may include:
- Resume screening
- Technical interview (eTMF / CTMS / Clinical Research)
- Managerial discussion
- HR round and final offer
How to Apply
Interested candidates can apply via email:
📧 Send your updated CV to: rahulkumar.cr@merillife.com
📌 Suggested Subject Line: Application for eTMF & CTMS Specialist – IndiaPharmaJobs.in
Important Dates
- Application Deadline: Not specified (apply early for better chances)
Why Apply for This Pharma Job?
This role is ideal for professionals looking to specialize in clinical trial systems and digital research operations. With increasing reliance on eTMF and CTMS platforms, this experience is highly valuable for long-term career growth.
Key advantages include:
- Work with advanced clinical trial technologies
- Gain exposure to global regulatory standards and audits
- Enhance expertise in TMF management and data integrity
- Collaborate with cross-functional clinical teams
- Strong career progression in CROs and pharmaceutical companies
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with Meril Life Sciences Pvt Ltd or any employer mentioned. Candidates are advised to verify details from official sources before applying. We do not charge any fees for job postings or applications.
Final Call-to-Action
If you have experience in eTMF and CTMS systems and want to grow in clinical research operations, apply now. Take the next step toward a rewarding career in clinical trials and regulatory compliance.
