A new opportunity has opened for the position of Clinical Document Specialist I in Pune, Maharashtra. This role is ideal for life sciences graduates with knowledge of clinical trial documentation, eTMF management, and ICH-GCP guidelines who want to start or grow their career in clinical research documentation and trial master file management.
The Clinical Document Specialist role focuses on maintaining the electronic Trial Master File (eTMF), reviewing clinical documents, and ensuring regulatory compliance. Professionals working in this role help maintain inspection readiness for clinical trials, making it a critical function within clinical research organizations and sponsor companies.
Candidates with 0โ1 year of experience in clinical research, clinical documentation, or TMF management are encouraged to apply.
Job Overview
- Position: Clinical Document Specialist I
- Location: Pune, Maharashtra, India
- Work Mode: On-site
- Job Type: Full-time, Permanent
- Experience: 0โ1 year
- Industry: Clinical Research / Life Sciences / CRO
Key Responsibilities
The Clinical Document Specialist I will manage and review clinical trial documentation while ensuring compliance with global regulatory standards.
Major responsibilities include:
- Review essential and non-essential Trial Master File (TMF) documents within the eTMF workflow.
- Perform initial indexing and accurate filing of documents in eTMF systems.
- Maintain quality thresholds and productivity targets defined in company SOPs.
- Ensure documents meet regulatory standards and sponsor expectations.
- Keep study trackers and documentation updated for project managers.
- Coordinate with Clinical Document Team Leads regarding project queries.
- Support User Acceptance Testing (UAT) during product development and system updates.
- Identify workflow challenges and proactively recommend solutions.
- Communicate effectively with internal teams and project stakeholders.
Eligibility Criteria
Candidates applying for the Clinical Document Specialist job in Pune should meet the following requirements.
Education
- Bachelorโs degree in Life Sciences, Pharmacy, Biotechnology, or related field
Experience
- 0โ1 year of experience in the Life Sciences industry
Required Skills
- Knowledge of clinical trial phases and clinical development processes
- Understanding of ICH-GCP guidelines and regulatory requirements
- Familiarity with essential clinical study documents and TMF structure
- Strong written and verbal communication in English
- Proficiency in Microsoft Office (Word, Excel, Outlook)
- Knowledge of eClinical technologies or eTMF systems is an advantage
- Strong attention to detail and document management skills
Benefits of This Role
Working as a Clinical Document Specialist in Pune offers several professional advantages:
- Exposure to global clinical trial documentation standards
- Opportunity to work with experienced clinical research teams
- Structured learning and development programs
- Career growth into roles such as:
- TMF Specialist
- Clinical Trial Associate
- Clinical Data Specialist
- Clinical Project Coordinator
- Hands-on experience with eClinical systems and regulatory documentation
Why This Role Matters in Clinical Research
The Trial Master File (TMF) is a critical component of clinical trials. Regulatory authorities such as FDA, EMA, and other global regulators inspect TMF documents to verify trial compliance.
A Clinical Document Specialist ensures:
- Proper document organization
- Regulatory compliance with ICH-GCP
- Readiness for regulatory inspections
This makes the role essential for maintaining quality and compliance in clinical studies.
How to Apply
