Novotech Hiring Senior Document Management Associate | Bangalore CRO Jobs
Are you seeking a Novotech Careers Bangalore or a Trial Master File Jobs India opportunity? Full-service global contract research organization (CRO) Novotech is hiring a Senior Document Management Associate (SDMA) at its Bangalore, India office.
This role is ideal for pharmacy and life sciences professionals with at least 2 years of experience in Trial Master File (TMF) handling, electronic database quality control (QC), and document tracking. To format your clinical document management resume, read our guide on how to apply for healthcare and pharma jobs online.
📋 Job Details
| Particular | Details |
|---|---|
| Company | Novotech (Novotech Global) |
| Position | Senior Document Management Associate (SDMA) |
| Job ID | 4152 |
| Job Location | Bangalore, Karnataka, India |
| Department | Clinical Operations / Document Management |
| Employment Type | Full-Time |
| Experience Required | Minimum 2 Years in TMF / Document Control |
| Qualifications | Bachelor's or Master's degree in Life Sciences, Pharmacy, or related field |
| Estimated Salary | As Per Industry Standards |
💼 Key Responsibilities
- Provide comprehensive support for Trial Master File (TMF) activities to clinical study teams for all assigned global projects.
- Manage both paper and electronic Trial Master Files (eTMF) in compliance with project plans, ICH-GCP rules, local/global regulatory standards, and Novotech/client SOPs.
- Perform detailed document quality control (QC) reviews, verifying metadata, resolution, and filing accuracy.
- Ensure the TMF remains in an audit-ready state through contemporaneous filing, indexing, and archiving.
- Track documentation collection timelines, generate quality logs, and report compliance metrics.
- Support study teams during internal audits, external sponsor reviews, and regulatory inspections.
- Liaise and collaborate effectively with clinical trial teams, sponsors, and third-party vendors.
- Help prepare documentation for study closeout and final archiving processes.
To learn how clinical operations and document management salaries compare to pharmacovigilance and drug safety tracks at CROs, read our report on Pharmacovigilance Salary: India vs USA.
🎓 Required Qualifications & Skills
- Education: Bachelor's degree in Life Sciences, Pharmacy, or related healthcare/scientific fields (B.Pharm, M.Pharm, Pharm.D, B.Sc, M.Sc).
- Experience: Minimum 2 years of experience in a CRO, pharmaceutical, or healthcare setting, with direct experience handling paper and electronic Trial Master Files (eTMF).
- Technical Skills: Proficiency with eTMF systems, SharePoint, document tracking tools, and performing comprehensive document quality control (QC) checks.
- Regulatory Knowledge: Solid understanding of ICH-GCP guidelines, clinical trial documentation requirements, and Good Documentation Practices.
- Soft Skills: Strong communication and teamwork abilities, detail-oriented, and excellent organizational skills.
For clinical document professionals looking to contrast advisory paths with laboratory pathways, read our analysis on B.Pharm Careers after Graduation: India vs USA.
🎁 Why Join Novotech?
- Global CRO operating across 34 offices worldwide with high ISO 27001 and ISO 9001 quality standards.
- Flexible work arrangements and employee wellness initiatives.
- Paid parental leave (available for both parents).
- Supportive company culture promoting diversity, equal opportunity, and career development.
To test your clinical operations knowledge, ICH guidelines, and basic TMF concepts before your interview, try our interactive Clinical Trial Assistant (CTA) Quiz.
💡 TMF Management vs Healthcare IT
Document Management Associates ensure clinical trial documentation is filed and verified in compliance with GCP rules, whereas Healthcare IT professionals maintain the technical servers and platforms. To explore these differences, read our comparison on Healthcare IT vs Clinical Healthcare.
📝 Resume Tips for Novotech Document Management Candidates
- Highlight eTMF Systems: Specifically list any eTMF platforms you have worked with, such as Veeva Vault, Documentum, or Phlexglobal.
- Emphasize Quality Control (QC): Focus on your experience performing comprehensive document reviews, verifying signatures, metadata checking, and resolving document discrepancies.
- Showcase Audit Experience: If you have participated in audit preparations, mock audits, or study closeouts, describe your role and the outcomes.
- Use Action Verbs: Start descriptions with words like "Managed," "Reviewed," "Audited," "Indexed," and "Archived."
💬 Novotech Document Management Associate Interview Questions
- Q1. What is the ALCOA+ framework and how does it apply to TMF management?
Answer Guidance: ALCOA+ defines data quality standards: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available. In TMF management, it ensures that every trial document is a high-quality, reliable, and compliant record. - Q2. How do you handle a missing essential document during a TMF quality review?
Answer Guidance: First, log the discrepancy in the document tracker. Then, coordinate with the Clinical Research Associate (CRA) or study team to identify where the document was generated and request the missing file, following up systematically until it is uploaded. - Q3. Why is contemporaneous filing important in Trial Master File operations?
Answer Guidance: Contemporaneous filing means uploading and indexing documents as soon as they are generated. This prevents a backlog of files, ensures real-time oversight of study progress, and keeps the TMF constantly inspection-ready for sudden regulatory audits.
🚀 How to Apply?
Interested and eligible candidates can submit their applications directly on Novotech's Oracle Cloud portal. Click the button below to apply:
Apply Online – Novotech Careers Portal❓ Frequently Asked Questions
Q. What is the experience requirement for this Novotech TMF position?
A minimum of 2 years of experience in a CRO, pharmaceutical, or healthcare setting is required, with prior experience handling paper or electronic TMFs.
Q. What is the work location for this Document Management Associate role?
This is a full-time position based at Novotech's Bangalore, Karnataka office.
Q. What benefits does Novotech offer to employees?
Novotech provides flexible work arrangements, paid parental leave for both parents, comprehensive health and wellness programs, and strong career progression paths.
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