Novotech Life Science Jobs as Document Management Associate
About Novotech
Novotech is a global full-service clinical Contract Research Organization (CRO) headquartered in Sydney, Australia. With 34 offices across Asia-Pacific, North America, and Europe, Novotech offers clinical development services across all trial phases and therapeutic areas. Committed to the highest standards in IT security and quality, Novotech provides an inclusive work environment and supports flexible working options and ongoing development programs.
Job Title: Document Management Associate (DMA)
Location: India
Job Description
The Document Management Associate (DMA) will provide support for Trial Master File (TMF) activities to the clinical teams. This role involves managing both electronic and paper TMFs according to project requirements, ICH GCP guidelines, and regulatory requirements.
Minimum Qualifications & Experience
- At least 12 months of experience in a clinical research organization or equivalent
- Practical experience in handling Trial Master File activities
- Prior background in pharmaceutical, CRO, or healthcare industry is advantageous
Responsibilities:
- Manage and maintain study documentation (electronic/paper TMF) per ICH GCP, Novotech/client SOPs.
- File, track, and quality-check documents using systems like SharePoint and eTMF; ensure timely uploads and organization.
- Ensure documents meet essential requirements; collaborate with teams to maintain quality.
- Provide regular updates and reports on TMF completeness and document quality.
- Keep TMF inspection-ready at all times; ensure timely, contemporaneous filing.
- Adhere to SOPs, KPIs, and TMF processes; perform interim exports and monthly file accuracy reviews.
- Support audits, TMF reviews, and study closeout preparations.
- Address quality control and audit findings.
- Maintain department reports, checklists, and quality schedules.
- Support TMF-related special projects and file archiving.
- Uphold Novotech policies and maintain professionalism in all external communications.
- Actively participate in Clinical Operations meetings and process improvements.
About the Team
At Novotech, employees work alongside empowered teams with a shared commitment to success. The culture fosters partnership and collaboration, providing ongoing support from senior stakeholders and leadership teams.
Keywords: Document Management Associate, Clinical Research, Trial Master File, TMF, Novotech, CRO, Healthcare, Quality Standards, Novotech Lifescience jobs Novotech Life Science Jobs as Document Management Associate
