Hollister Global Business Services India Private Limited is hiring for the position of Documentation Specialist I – Clinical Affairs in Gurugram, Haryana. This opportunity is suitable for professionals with a background in Life Sciences, Pharmacy, Nursing, Biomedical Sciences, Clinical Research, or related disciplines and relevant experience in clinical documentation or clinical operations.
The Hollister Documentation Specialist I Clinical Affairs role is part of the Global Clinical Affairs (GCA) – Clinical Operations team and primarily focuses on electronic Trial Master File (eTMF) management, clinical trial documentation, document quality control, inspection readiness, and regulatory compliance.
Candidates with hands-on exposure to Veeva Vault eTMF or comparable eTMF platforms, TMF Reference Model, ICH-GCP, ISO 14155, ALCOA+, SOP compliance, and clinical trial documentation may find this opportunity particularly relevant.
Job Overview
| Particular | Details |
|---|---|
| Company | Hollister Global Business Services India Private Limited |
| Position | Documentation Specialist I – Clinical Affairs |
| Function | Global Clinical Affairs – Clinical Operations |
| Location | Gurugram, Haryana, India |
| Job Type | Full-Time |
| Qualification | Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences or related discipline |
| Experience | Typically 2–5 years |
| Key Skills | eTMF, Veeva Vault, TMF, GCP, ISO 14155, ALCOA+, Clinical Documentation |
| Reports To | Manager, Clinical Operations / GCA |
About the Role
As a Documentation Specialist I – Clinical Affairs, the selected candidate will support the Global Clinical Affairs Clinical Operations team throughout the lifecycle of clinical trial and clinical investigation documentation.
A major responsibility of this position is maintaining the electronic Trial Master File (eTMF) and ensuring essential clinical documents remain complete, accurate, current, traceable, and compliant with applicable procedures.
The Documentation Specialist also contributes to maintaining continuous audit and regulatory inspection readiness across assigned clinical studies.
Key Responsibilities
- Manage the setup, maintenance, quality control, close-out, and archival of the electronic Trial Master File (eTMF) for assigned clinical studies.
- Process clinical documents within the eTMF, including indexing, classification, filing, versioning, and document tracking.
- Ensure documentation is maintained according to the applicable TMF Reference Model, study-specific TMF plans, SOPs, and work instructions.
- Conduct completeness, consistency, and quality reviews of incoming clinical documents.
- Identify missing, expired, incomplete, or non-compliant documentation and coordinate with document owners for resolution.
- Work with assigned study teams to identify documents that must be collected before, during, and after clinical study conduct.
- Maintain GCA’s TMF tracker and ensure appropriate visibility of TMF compliance status, documentation gaps, and outstanding actions.
- Escalate significant documentation gaps and compliance risks to Clinical Operations leadership.
- Support ongoing inspection and audit readiness by ensuring that the eTMF remains current.
- Assist with document preparation, retrieval, and review during internal audits and regulatory inspections.
- Act as a day-to-day resource for eTMF-related activities and documentation processes.
- Maintain appropriate version control for controlled documents and templates.
- Support document change-control activities in accordance with company SOPs.
- Collaborate with Clinical Operations, Regulatory Affairs, Quality teams, CROs, vendors, and other stakeholders.
- Support the development, review, and periodic revision of SOPs, work instructions, and TMF-related documentation.
- Participate in continuous improvement initiatives related to clinical documentation processes and eTMF systems.
- Ensure documentation activities comply with GCP, ISO 14155, applicable regulatory requirements, ALCOA+ data integrity principles, and company policies.
Qualification and Eligibility
Candidates should have a Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Biomedical Sciences, or a related discipline.
Relevant degrees may therefore include backgrounds such as:
B.Pharm / B.Sc Life Sciences / B.Sc Nursing / Biomedical Sciences / Clinical Research or other relevant scientific disciplines.
The official job description also states that equivalent relevant experience may be considered.
Experience Required
Hollister specifies typically 2–5 years of relevant experience in areas such as:
- Clinical documentation
- TMF/eTMF management
- Clinical trial administration
- Clinical operations
Experience may come from a pharmaceutical, biotechnology, medical device, or CRO environment.
Candidates should also have hands-on experience with an eTMF platform such as Veeva Vault eTMF or a comparable system.
Previous experience supporting regulatory inspections or audits is strongly preferred.
Skills Required
Candidates should possess a solid understanding of:
- Electronic Trial Master File (eTMF)
- Trial Master File principles
- TMF Reference Model
- Clinical trial essential documents
- Document lifecycle management
- Veeva Vault eTMF or comparable systems
- ISO 14155 Good Clinical Practice
- ICH-GCP E6
- ALCOA+ data integrity principles
- SOP compliance
- Document quality control
- Inspection and audit readiness
- Document version control
- Electronic document management systems
- Microsoft Office
- Smartsheet
Strong attention to detail, organization, problem-solving, written communication, verbal communication, and cross-functional collaboration are also important for this role.
Who Should Apply?
This Hollister Clinical Affairs job in Gurugram may be suitable for professionals currently working as a:
- TMF Associate
- eTMF Specialist
- TMF Coordinator
- Clinical Trial Assistant
- Clinical Documentation Specialist
- Clinical Operations Associate
- Clinical Trial Coordinator
- Document Management Associate
- Clinical Research Associate supporting TMF activities
Candidates with relevant eTMF and clinical documentation experience who want to build their careers in Clinical Operations may consider applying.
Why Consider This Opportunity?
The role provides exposure to several important areas of clinical research operations, including global clinical documentation, eTMF management, clinical study lifecycle activities, regulatory compliance, inspection readiness, SOP management, and cross-functional clinical operations.
The position can be particularly relevant for professionals interested in developing deeper expertise in TMF/eTMF operations and clinical documentation compliance within a global clinical affairs environment.
Salary
Hollister has not disclosed an official salary range in the provided job posting.
For structured-data purposes, an estimated market range for a Documentation Specialist with approximately 2–5 years of relevant clinical operations/eTMF experience in Gurugram may be around ₹5,00,000–₹10,00,000 per year.
Important: This is an estimated market range only and is not an officially disclosed Hollister salary. Actual compensation may vary based on experience, skills, internal compensation structure, and other factors.
How to Apply
