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Are you an experienced clinical research professional looking to grow your career in Trial Master File (TMF) management? Novotech – Asia-Pacific’s leading Clinical Research Organization (CRO) – is currently hiring a Clinical Document Specialist (CDS) in its Bangalore office.
This role is ideal for professionals who have strong experience in TMF/eTMF documentation, quality control, and ICH-GCP compliance, and want to work with global biotech and pharma clients.
In this detailed article, you will find complete information about the role, responsibilities, qualifications, salary estimate, work environment, and the official application link.
About Novotech – A Leading Global CRO:-
Novotech is one of the world’s fastest-growing Contract Research Organizations, with operations across Asia-Pacific, the US, and Europe. It is known for:
Strong quality standards
Global clinical operations
Advanced eTMF systems
Employee-friendly culture
Continuous training and development
The company supports biotech and pharmaceutical clients in conducting high-quality clinical trials and maintaining regulatory-compliant documentation.
Role Overview: Clinical Document Specialist (TMF/eTMF):-
The Clinical Document Specialist plays a critical role in managing clinical trial documents and ensuring they meet global quality, regulatory, and compliance standards.
You will manage both electronic TMF (eTMF) and paper TMF and support study teams across multiple clinical operations projects.
Key Responsibilities (Detailed):-
As a Clinical Document Specialist, your day-to-day responsibilities will include:
1. Managing TMF and eTMF Documentation:
Uploading study documents into the eTMF system
Ensuring correct naming conventions and metadata
Performing quality control (QC) checks
Maintaining TMF completeness and consistency
✔ 2. Client & Stakeholder Coordination:
Interacting with sponsors and alliance partners
Understanding client-specific TMF requirements
Communicating TMF updates and resolving issues
✔ 3. Training & Mentoring:
Training new team members
Supporting team leads in process improvements
Sharing best practices for TMF maintenance
✔ 4. Regulatory Compliance:
Ensuring adherence to ICH-GCP guidelines
Supporting audit- and inspection-readiness
Managing updates as per regulatory changes
✔ 5. Operational & Documentation Support:
Supporting TMF filing plans
Participating in clinical operations discussions
Assisting in paper TMF archival and storage
Ensuring documents are inspection-ready
This role is ideal for individuals who are detail-oriented, organized, and experienced in documentation & compliance.
Eligibility & Qualifications:-
To apply for this position, you must meet the following requirements and Information:
✔ Educational Qualification
Bachelor’s Degree in Life Sciences (mandatory)
Preferred: B.Pharm, M.Sc, B.Sc in biological sciences
✔ Experience
Minimum 5 years of experience in:
TMF/eTMF management
Clinical research
Clinical operations documentation
✔ Skills Required
Strong expertise in TMF workflows
Familiarity with global TMF processes
Understanding of ICH-GCP guidelines
Experience working in the CRO/pharma industry
Excellent communication and documentation skills
Attention to detail
Ability to manage multiple study documents
If you have hands-on experience with any eTMF platform, your application becomes even stronger.
Why Join Novotech? (Benefits & Work Culture):-
Novotech is known for its employee-friendly and flexible culture. Some key benefits include:
Work-Life Balance & Flexibility
Hybrid work options
Employee wellness programs
Working with global teams
Growth & Development
Training programs
Career advancement opportunities
Exposure to global biotech clinical trials
Inclusive Culture
Support for LGBTQ+, caregivers, and diverse communities
Equal opportunities and fair hiring practices
Parental leave for all genders
This role is perfect for professionals seeking long-term stability and growth in documentation & TMF management.
Job Location:-
Novotech, Ground Floor, Unit 1, Block E, Helios Business Park, Bangalore – 560103
This location is a major corporate hub with good connectivity.
Estimated Salary Range
Based on industry standards for TMF professionals in India:
₹6,50,000 – ₹12,00,000 per year
Salary depends on experience, skillset, and interview performance.
How to Apply (Direct Link):-
Click below to apply on the official Novotech career portal:
If you are a clinical research professional with strong TMF or eTMF experience, this role at Novotech is an excellent opportunity to advance your career.
The work environment, learning opportunities, and global exposure make it a highly attractive position for documentation-focused professionals in the clinical research industry.
Apply today and take a strong step toward your next career milestone!
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