Looking for the latest TMF Specialist jobs in India? OrciMed Life Sciences is currently hiring experienced professionals for the role of TMF Specialist. Candidates with strong experience in Trial Master File (TMF) management, FDA regulations, ICH-GCP compliance, and electronic TMF systems are encouraged to apply.
This is an excellent opportunity for life sciences professionals seeking career growth in clinical research documentation, regulatory compliance, and TMF operations.
About the TMF Specialist Role
The TMF Specialist will be responsible for maintaining accurate and compliant Trial Master File documentation in accordance with FDA, ICH, and GCP guidelines. The role requires collaboration with cross-functional teams in a matrix work environment while ensuring inspection readiness and document quality.
Professionals with prior experience in electronic TMF systems and clinical trial documentation management will have an advantage.
Key Responsibilities
- Manage and maintain Trial Master File (TMF) documentation
- Ensure compliance with FDA, ICH, and GCP guidelines
- Perform TMF quality checks and reconciliation activities
- Support inspection readiness for clinical trials
- Work with cross-functional and global study teams
- Maintain electronic TMF systems and documentation workflows
- Identify missing, incomplete, or inaccurate documents
- Ensure timely filing and organization of study documents
Qualifications Required
- Bachelor’s degree in Life Sciences or related field
- Minimum 3+ years of TMF experience
- Strong understanding of FDA, ICH, and GCP guidelines
- Experience working with electronic TMF systems
- Prior experience in a cross-matrix work environment
- Good communication and organizational skills
- Attention to detail and compliance-focused mindset
Preferred Skills
- Clinical trial documentation expertise
- Regulatory compliance knowledge
- Electronic document management systems experience
- Audit and inspection readiness support
- Team collaboration and stakeholder coordination
Salary and Benefits
Expected salary for this TMF Specialist role may range between ₹6 LPA – ₹10 LPA, depending on experience and expertise.
Benefits may include:
- Competitive salary package
- Career growth opportunities in clinical research
- Exposure to global clinical trials
- Professional development opportunities
- Collaborative work culture
How to Apply
Interested candidates can send their updated resume to:
careers@orcimedlifesciences.com
