Clinical research organization (CRO) jobs in India continue to grow rapidly, and Novotech is currently hiring for the role of Senior Document Management Associate (SDMA) in Bangalore. This opportunity is ideal for professionals with experience in Trial Master File (TMF) management, eTMF operations, and clinical documentation within the pharmaceutical or CRO industry.
Candidates with more than 2 years of experience in clinical research documentation, TMF quality control, and regulatory filing processes can apply for this Bangalore-based full-time role.
Job Overview
| Details | Information |
|---|---|
| Job Title | Senior Document Management Associate |
| Company | Novotech |
| Location | Bangalore, Karnataka, India |
| Department | Clinical Operations / TMF |
| Employment Type | Full-Time |
| Experience Required | 2+ Years |
| Industry | Clinical Research / CRO |
| Job ID | 4024 |
About Novotech
Novotech Careers is a globally recognized Contract Research Organization (CRO) providing clinical research and scientific advisory services across Asia-Pacific, Europe, and the United States. The company is known for supporting biotech and pharmaceutical companies with clinical trial management, regulatory expertise, and operational excellence.
With over 30 global offices, Novotech offers strong career growth opportunities for professionals in clinical operations, TMF management, data management, and regulatory affairs.
Senior Document Management Associate Job Responsibilities
The Senior Document Management Associate (SDMA) will support Trial Master File (TMF) activities and ensure all study documentation complies with ICH-GCP guidelines, regulatory requirements, and company SOPs.
Key Responsibilities Include:
- Manage paper and electronic Trial Master Files (eTMF)
- Upload, scan, track, and maintain clinical trial documents
- Perform TMF quality control (QC) reviews
- Ensure TMF remains inspection-ready at all times
- Support audits and regulatory inspections
- Prepare monthly TMF reports and QC schedules
- Coordinate with internal and external clinical study teams
- Mentor and train new Document Management Associates
- Resolve audit findings and QC queries within timelines
- Maintain compliance with SOPs, KPIs, and clinical documentation standards
This clinical research documentation role requires strong organizational skills and attention to detail, especially in handling regulatory and study-related records.
Required Qualifications
Candidates applying for the Senior Document Management Associate job in Bangalore should meet the following criteria:
Educational Qualification
- Bachelorโs degree in Life Sciences, Pharmacy, Biotechnology, or related field preferred
Experience
- Minimum 2 years of experience in:
- Trial Master File (TMF) management
- Electronic TMF (eTMF) systems
- Clinical documentation processes
- CRO or pharmaceutical industry operations
Preferred Skills
- Knowledge of ICH-GCP guidelines
- Experience with SharePoint and document management systems
- Understanding of clinical trial workflows
- Strong communication and QC review skills
- Ability to manage timelines and compliance activities
Benefits of Working at Novotech
Novotech offers a collaborative and employee-focused workplace environment with several benefits, including:
- Flexible work culture
- Career development programs
- Global clinical research exposure
- Wellness initiatives
- Mentorship and leadership support
- Inclusive workplace policies
- Opportunities to work on cutting-edge biotech and pharmaceutical studies
The company has also been recognized as an Employer of Choice and Great Place to Work.
How to Apply
