Novotech Hiring Senior Document Management Associate | TMF & eTMF Clinical Research Jobs
Novotech is hiring Senior Document Management Associates for its TMF and Clinical Operations team in Bangalore.
This opportunity is ideal for professionals interested in Trial Master File (TMF), eTMF Operations, Clinical Documentation, Regulatory Compliance, Inspection Readiness, and CRO careers.
📋 Job Overview
- Company: Novotech
- Role: Senior Document Management Associate
- Location: Bangalore
- Department: Clinical Operations / TMF
- Industry: Clinical Research / CRO
- Experience: 2–5 Years
- Employment Type: Full-Time
- Job ID: 4024
🏢 About Novotech
Novotech is a globally recognized Contract Research Organization (CRO) providing clinical trial management, regulatory support, and scientific advisory services to pharmaceutical and biotechnology companies worldwide.
The company operates across Asia-Pacific, Europe, and the United States with strong expertise in clinical operations, TMF management, and regulatory compliance.
📌 Key Responsibilities
- Manage paper and electronic Trial Master Files (eTMF)
- Upload, scan, track, and maintain clinical study documents
- Perform TMF quality control reviews
- Ensure TMF remains inspection-ready
- Support audits and regulatory inspections
- Prepare TMF reports and QC schedules
- Coordinate with internal and external study teams
- Resolve audit findings and QC queries
- Maintain compliance with SOPs and KPIs
- Mentor junior document management associates
🎓 Eligibility Criteria
Required Qualification
- B.Pharm / M.Pharm / Pharm.D
- BSc / MSc Life Sciences
- Biotechnology or Related Fields
🧑💻 Experience Required
- 2+ Years in TMF / eTMF Operations
- Clinical Documentation Experience Preferred
- CRO or Pharmaceutical Industry Experience
⭐ Required Skills
- ICH-GCP knowledge
- TMF quality control expertise
- SharePoint & document management systems
- Clinical trial workflow understanding
- Strong organizational skills
- Communication & compliance management
🌍 Benefits of Working at Novotech
- Global clinical research exposure
- Career development opportunities
- Flexible work culture
- Mentorship and leadership support
- Exposure to global biotech and pharma studies
- Inclusive and employee-focused environment
- Professional learning opportunities
📄 Resume Tips for TMF & Clinical Documentation Roles
- Highlight TMF/eTMF experience clearly
- Mention inspection readiness and audit support activities
- Add experience with SharePoint or document management systems
- Include ICH-GCP and SOP compliance knowledge
- Mention quality control and documentation review activities
- Keep your resume ATS-friendly and concise
🎯 Interview Tips for Novotech TMF Roles
- Prepare questions on TMF lifecycle management
- Revise ICH-GCP guidelines and inspection readiness concepts
- Understand essential clinical trial documents
- Be ready to explain audit and QC handling processes
- Review eTMF systems and document workflows
- Demonstrate communication and coordination abilities
📝 How to Apply for Novotech Jobs
Before applying, make sure your resume is updated with relevant TMF, eTMF, clinical documentation, and CRO experience.
🚀 Job Application Link
Please make sure to read the complete job description carefully before submitting your application. Strong understanding of TMF workflows, eTMF systems, inspection readiness, and clinical documentation standards significantly improves your chances of selection.
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