Novotech is hiring for a Document Management Associate (Clinical Document Specialist) in India. The role focuses on Trial Master File (TMF) management, clinical trial document handling, document quality control, and maintenance of electronic and paper-based Trial Master Files.
The selected candidate will support clinical operations teams by ensuring essential clinical trial documents are managed in compliance with ICH-GCP guidelines, regulatory requirements, and Novotech/client Standard Operating Procedures (SOPs).
Job Details
| Particulars | Details |
|---|---|
| Company | Novotech |
| Job Title | Document Management Associate (Clinical Document Specialist) |
| Job Category | Clinical Operations / TMF Management |
| Job Location | India |
| Industry | Clinical Research / CRO |
| Experience | Minimum 5 Years |
| Qualification | Bachelor’s Degree in Life Sciences |
| Employment Type | Full-time |
Position: Document Management Associate (Clinical Document Specialist)
The Clinical Document Specialist (CDS) will be responsible for managing and maintaining Trial Master Files (TMFs) for assigned clinical research projects. The role involves document uploading, quality control reviews, electronic and paper-based document management, and coordination with clinical teams and external clients.
Key Responsibilities
- Manage and maintain Trial Master Files (TMF), including electronic and paper-based records.
- Perform document uploading and quality control (QC) reviews.
- Ensure clinical trial documentation complies with ICH-GCP guidelines, regulatory requirements, and company/client SOPs.
- Coordinate directly with clients and alliance partners regarding assigned responsibilities.
- Support the development and maintenance of team training programs.
- Train and mentor new team members.
- Identify and lead TMF process improvement initiatives to improve centralized workflows and operational efficiency.
- Support the development of project-specific Filing Plans in collaboration with Team Leads and Project Managers.
- Monitor customer satisfaction and resolve documentation-related issues with internal and external stakeholders.
- Maintain paper file locations and archived study documentation.
- Support the review and maintenance of Clinical Operations processes, tools, and SOPs.
- Stay updated on regulatory requirements and changes related to TMF management.
- Participate in Clinical Operations meetings and contribute to clinical process development.
Eligibility Criteria / Qualifications
Candidates applying for the Novotech Document Management Associate position should meet the following requirements:
- Bachelor’s Degree with a concentration in Life Sciences.
- 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 paper-based TMF or electronic Trial Master Files (eTMF).
- Background in the pharmaceutical, CRO, or healthcare industry is advantageous.
Required Skills
- Knowledge of Trial Master File (TMF) management.
- Practical experience with electronic Trial Master File (eTMF) systems.
- Clinical trial document management and quality control.
- Understanding of ICH-GCP guidelines.
- Knowledge of regulatory requirements and clinical documentation processes.
- Client and stakeholder coordination.
- Training, mentoring, and team collaboration.
- Process improvement and centralized workflow management.
- Ability to identify operational issues and make proactive decisions.
About Novotech
Novotech is a global full-service Contract Research Organization (CRO) established in 1997. The company provides clinical research and scientific advisory services, supporting the development of therapies across global markets.
Novotech operates through more than 30 offices across Asia-Pacific, the United States, and Europe, working with biotechnology and pharmaceutical companies on clinical research programs.
The organization offers mentorship opportunities, professional development programs, flexible working options, paid parental leave, flexible leave entitlements, and wellness programs.