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Document Management Associate

Novotech
NovoTech
0-3 years
Not Disclosed
India
10 April 6, 2026
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Document Management Associate | Full-Time | India
Experience Required: 0-3 years

Job Description:
We are looking for a detail-oriented Document Management Associate (DMA) to support clinical trial operations in India. This role focuses on managing Trial Master Files (TMF) and ensuring that all study documentation is accurate, complete, and compliant with regulatory standards. The DMA will work closely with internal and external study teams to maintain high-quality documentation for clinical studies.

Key Responsibilities:

  • Manage Trial Master Files (TMF) in both electronic and paper formats according to project requirements.

  • Ensure TMF compliance with ICH-GCP guidelines, local/global regulatory requirements, and company/client SOPs.

  • Coordinate with clinical teams to track, file, and archive study documents efficiently.

  • Conduct regular TMF quality checks and reconcile discrepancies.

  • Support audits and inspections by providing timely and accurate documentation.

  • Assist in implementing and maintaining document management processes and best practices.

Qualifications & Experience:

  • Bachelor’s degree in Life Sciences, Pharmacy, or a related field.

  • 0-3 years of experience in clinical document management or trial master file support.

  • Familiarity with TMF systems, regulatory documentation standards, and ICH-GCP guidelines.

  • Strong organizational skills, attention to detail, and ability to manage multiple priorities.

  • Excellent communication and collaboration skills for working with cross-functional teams.

Location: India (flexible across major cities)

Why Join Us:

  • Contribute to global clinical research projects with a focus on quality and compliance.

  • Gain exposure to TMF management, clinical operations, and regulatory standards.

  • Opportunities for career growth, professional development, and cross-functional collaboration.