Location: Pune, Maharashtra, India
Work Mode: On-site (Work from Office Mandatory)
Department: Localization / Clinical Documentation
Job Type: Full-Time, Permanent
Company: TransPerfect
Experience Required: Minimum 2 Years Experience (Freshers Not Eligible)
About the Role
TransPerfect is hiring for the position of Clinical Document Specialist I in Pune. This opportunity is ideal for experienced clinical research professionals looking to build expertise in eTMF management, clinical documentation review, and inspection readiness within a global clinical operations environment.
The role focuses on reviewing and managing Trial Master File (TMF) documents, ensuring regulatory compliance, maintaining document quality standards, and supporting clinical study documentation processes aligned with ICH-GCP guidelines.
Key Responsibilities
Review essential and non-essential TMF documents within eTMF workflows for accurate indexing and filing
Ensure clinical trial documents are maintained according to sponsor expectations and regulatory standards
Maintain productivity and quality benchmarks as per organizational SOPs
Identify process gaps proactively and recommend operational improvements
Coordinate effectively with internal stakeholders and Clinical Document Team Leads for project-related activities
Maintain study trackers and ensure timely communication with relevant teams
Support User Acceptance Testing (UAT) during product development and system releases
Perform additional clinical document review activities beyond eTMF as assigned
Contribute toward inspection readiness and documentation compliance initiatives
Eligibility Criteria
Educational Qualification
Bachelor’s Degree in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or related healthcare disciplines
Experience Required
Minimum 2 years of clinical research experience
Freshers are not eligible for this role
Preferred Industry Experience
Candidates with hands-on experience in any of the following areas will be preferred:
Site Management
Site Start-Up Activities
eISF Management
Pharmacovigilance
CTMS (Clinical Trial Management Systems)
Medical Writing
Regulatory Submissions
HIPAA & Compliance
Clinical Data Management
Clinical Documentation Operations
Required Skills
Strong understanding of ICH-GCP guidelines and clinical development processes
Knowledge of essential clinical trial documents and TMF structure
Excellent written and verbal communication skills in English
Ability to work in timeline-driven clinical environments
Strong attention to detail and quality-focused mindset
Proficiency in Microsoft Office tools including Word, Excel, and Outlook
Familiarity with eClinical technologies will be an added advantage
Positive learning attitude with adaptability to new systems and workflows
Work Timings
Shift Timing: 9:30 AM – 6:30 PM (General Shift)
Job Location
Aundh, Pune, Maharashtra, India
Pune
Why This Opportunity Matters
This role offers excellent exposure to:
Global clinical trial documentation workflows
eTMF systems and regulatory documentation management
Inspection readiness practices in clinical research
Career growth opportunities within clinical operations and document management domains
Professionals aiming to transition into advanced clinical operations, TMF management, or global clinical documentation careers can significantly benefit from this opportunity.
How to Apply
Interested and eligible candidates can share their updated resume directly with:
Hritik Kale
Email: hritik.kale@transperfect.com
Keywords for Job Search
Clinical Document Specialist Jobs in Pune, eTMF Jobs in India, Clinical Research Jobs Pune, TMF Specialist Careers, Clinical Documentation Jobs 2026, Pharmacovigilance and Clinical Operations Jobs, ICH GCP Jobs India, Clinical Trial Documentation Careers, TransPerfect Careers Pune, Clinical Research Experienced Jobs India
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