Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. We’re seeking a skilled Senior TMF Specialist to join our team in Bengaluru, India.
About the Role π
As a Sr. TMF Specialist, you’ll be responsible for driving the TMF to be inspection-ready, managing essential clinical trial documents, and ensuring compliance with SOPs and regulatory guidelines.
Responsibilities π
Act as an SME on eTMF applications, TMF processes, and document identification/filing
Own the TMF Plan/Index and lead the identification of expected documents
Build relationships with sponsor counterparts and provide inputs on best industry practices
Ensure TMF file structure follows applicable company-approved TMF configuration and ICH Guidelines
Contribute to mentoring and grooming TMF Specialists’ TMF-related competencies
Requirements π
Bachelor’s degree in a scientific discipline
3+ years of Clinical Operations experience in TMF Operations
Knowledge of filing procedures and eTMF application
Prior experience in maintaining the TMF inspection-ready and/or identifying TMF completeness gaps
Experience in Veeva is highly desirable
What We Offer π
Competitive salary and benefits
Opportunities for growth and learning
Collaborative and dynamic work environment
Training and development programs
How to Apply π§
If you’re a motivated and detail-oriented professional looking for a challenging role in clinical research, apply now ππ»: https://careers.emmes.com/jobs/2719?lang=en-us
About Emmes Group π
Emmes Group is a leading clinical research organisation, committed to delivering high-quality services and driving innovation in healthcare.
Conclusion π
Join Emmes Group and be part of a dynamic team driving innovation in clinical research! Apply now and take your career to the next level!
I am keenly looking for an opportunity into eTMF and clinical research
Thank you for your interest. Please share your updated resume at the email ID mentioned in the post