TransPerfect is hiring Clinical Document Specialists in Pune for professionals with experience in clinical research documentation, TMF management, and regulatory compliance. This opportunity is ideal for candidates with 0โ2 years of experience in clinical research, pharmacovigilance, data management, or regulatory documentation who want to build a career in clinical trial documentation and eTMF operations.
The Clinical Document Specialist role focuses on maintaining Trial Master File (TMF) documentation, performing quality checks of clinical trial documents, and ensuring compliance with ICH-GCP guidelines and global regulatory standards.
This role offers an excellent entry point for pharmacy graduates, life sciences graduates, and clinical research professionals aiming to work in clinical operations, TMF management, or clinical documentation management.
Job Overview
| Parameter | Details |
|---|---|
| Position | Clinical Document Specialist |
| Company | TransPerfect |
| Location | Pune, Maharashtra, India |
| Experience | 0โ2 Years |
| Qualification | Bachelorโs Degree (Pharmacy / Life Sciences preferred) |
| Employment Type | Full-time |
| Work Mode | Work From Office |
| Shift | 9:30 AM โ 6:30 PM |
| Openings | 10 |
Key Responsibilities
As a Clinical Document Specialist, your primary responsibilities will include:
Clinical Documentation & TMF Management
- Perform first-level quality control (QC) of clinical trial documents.
- Review and process essential and non-essential Trial Master File (TMF) documents.
- Ensure accurate document indexing and filing in electronic TMF (eTMF) systems.
Compliance & Regulatory Documentation
- Maintain documentation according to ICH-GCP guidelines and regulatory requirements.
- Ensure clinical trial documentation is inspection-ready.
Project Coordination
- Maintain study trackers and documentation logs.
- Coordinate with clinical document team leads and internal project stakeholders.
- Address document processing queries and ensure proper documentation workflows.
Process Improvement & System Support
- Identify operational challenges and suggest improvements.
- Support User Acceptance Testing (UAT) during system upgrades or releases.
- Maintain productivity and quality standards defined by organizational SOPs.
Required Qualifications
Candidates applying for this Clinical Document Specialist job in Pune should meet the following requirements:
Educational Qualification
- Bachelorโs degree in Pharmacy, Life Sciences, Clinical Research, or related field.
Experience
- 0โ2 years of experience in clinical research or related areas such as:
- Clinical Data Management
- Pharmacovigilance
- Regulatory Submissions
- Medical Writing
- Site Management
- CTMS or eClinical technologies
Technical Knowledge
- Understanding of clinical trial phases and processes
- Knowledge of ICH-GCP guidelines
- Familiarity with Trial Master File (TMF) and eTMF systems
- Experience with Microsoft Office (Word, Excel, Outlook)
Skills
- Strong attention to detail
- Good communication and documentation skills
- Ability to manage timelines and project documentation
- Willingness to learn new clinical technologies and systems
Why Join TransPerfect?
Working as a Clinical Document Specialist at TransPerfect offers multiple career advantages:
- Exposure to global clinical trials
- Experience in TMF management and regulatory documentation
- Opportunities to work with international CRO clients
- Structured learning and development programs
- Growth opportunities in clinical operations and documentation management
This role can serve as a stepping stone toward careers such as:
- Clinical Trial Associate
- TMF Specialist
- Clinical Operations Associate
- Clinical Data Manager
- Regulatory Affairs Specialist
How to Apply
Interested candidates can apply by sending their updated resume to:
Email: hritik.kale@transperfect.com
