Are you an experienced clinical research professional looking to advance your career in Trial Master File (TMF) management? Novotech, a leading global CRO, is hiring a Clinical Document Specialist (CDS) in Bangalore. This is an excellent opportunity for skilled TMF professionals to work with a world-class team supporting innovative biotech and clinical research programs.
In this role, you will manage both electronic TMF (eTMF) and paper TMF systems, support clinical operations, ensure documentation compliance with ICH-GCP, and collaborate closely with internal teams and clients.
⭐ Key Responsibilities
As a Clinical Document Specialist, you will:
- Perform document uploading and quality control (QC) review as per Novotech SOPs
- Liaise with clients/alliance partners for allocated TMF responsibilities
- Mentor and train new team members in TMF workflows
- Lead TMF process improvements and workflow optimizations
- Support filing plan development with Team Leads/Project Managers
- Ensure TMF compliance with regulatory updates and GCP guidelines
- Assist in managing the DMA team when required
- Evaluate customer satisfaction and address TMF-related issues
- Participate in clinical operations meetings and contribute to SOP improvements
- Support archived study maintenance and paper file organization
- Ensure high-quality documentation management aligned with Novotech standards
🎓 Eligibility & Qualifications
- Bachelor’s Degree in Life Sciences (minimum requirement)
- 5+ years of experience in clinical research or related functions
- Hands-on expertise in TMF/eTMF management
- Experience in pharmaceutical, CRO, or healthcare industries preferred
- Strong understanding of eTMF systems, GCP, and clinical operations
- Excellent communication, documentation, and organizational skills
💼 Why Join Novotech? (Benefits & Culture)
Novotech offers an inclusive, supportive, and flexible work environment:
- Flexible working options
- Paid parental leave for all genders
- Wellness programs & training opportunities
- Inclusive environment supporting LGBTIQ+, caregivers, and people with disabilities
- Structured career development
- Collaborative, global clinical operations culture
- Commitment to gender equality and fair hiring practices
📍 Job Location
Ground Floor, Unit 1, Block E, Helios Business Park, Bangalore – 560103, India
💰 Salary Range (Estimated)
INR 6,50,000 – 12,00,000 per annum
(Industry-standard estimate for Clinical Document Specialist roles in India.)
📝 How to Apply
