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Company: Novotech
Job Title: Document Management Associate (Clinical Document Specialist – CDS)
Location: Bengaluru, Karnataka, India
Industry: Clinical Research / Pharmaceutical / Biotechnology
Department: Clinical Operations / Trial Master File (TMF) Management
Job Type: Full-Time
Experience: Minimum 5 Years
Qualification: Bachelor’s Degree in Life Sciences
About Novotech
Novotech is a global full-service Contract Research Organization (CRO) providing clinical research and scientific advisory services. The company is recognized for its workplace culture, innovation, and commitment to professional development.
Novotech is looking for an experienced Document Management Associate / Clinical Document Specialist to support Trial Master File (TMF) activities and ensure the quality, accuracy, and compliance of clinical trial documentation.
Job Description
The selected candidate will be responsible for managing and maintaining essential clinical trial documents, including electronic and paper-based Trial Master Files (eTMF/TMF). The role involves document uploading, quality control reviews, regulatory compliance, process improvement, and coordination with clinical teams and clients.
The candidate should have practical experience in TMF management, good knowledge of eTMF systems, and an understanding of ICH-GCP guidelines and regulatory requirements.
Key Responsibilities
- Manage and maintain Trial Master Files (TMF), including electronic and paper-based documentation.
- Perform document uploading and Quality Control (QC) reviews.
- Ensure compliance with ICH-GCP guidelines, regulatory requirements, and company SOPs.
- Coordinate with clients and alliance partners regarding assigned responsibilities.
- Support training programs and mentor new team members.
- Identify and implement TMF process improvements to enhance operational efficiency.
- Assist in developing project-specific TMF Filing Plans.
- Monitor document quality and ensure timely resolution of documentation issues.
- Support archived study maintenance and paper file organization.
- Contribute to the review and improvement of Clinical Operations processes, tools, and SOPs.
- Maintain effective communication with internal and external stakeholders.
Eligibility Criteria
Educational Qualification:
- Bachelor’s Degree in Life Sciences.
Experience:
- Minimum 5 years of experience in a Clinical Research Organization (CRO) or an equivalent role.
- Practical experience in Trial Master File (TMF) activities.
- Experience handling electronic TMF (eTMF) and paper-based documentation.
Required Skills:
- Good knowledge of eTMF systems.
- Understanding of ICH-GCP guidelines.
- Knowledge of clinical trial documentation and regulatory requirements.
- Document management and quality control skills.
- Strong communication and coordination abilities.
Why Join Novotech?
- Inclusive and supportive work environment.
- Flexible working options.
- Paid parental leave.
- Wellness programs.
- Ongoing learning and development opportunities.
- Career growth in the global clinical research industry.
Job Location
Bengaluru, Karnataka, India.
Interested candidates are encouraged to apply through Novotech’s official careers portal.
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