Clinical Document Specialist Freshers Job at TransPerfect in Pune for pharmacy and life sciences freshers with clinical research documentation experience.
Clinical Document Specialist Job at TransPerfect – Freshers Clinical Research Opportunity
Introduction
TransPerfect has announced an opportunity for the position of Clinical Document Specialist at its Pune office. This role is suitable for freshers and early-career professionals who want to build a career in clinical research documentation, Trial Master File (TMF) management, and regulatory compliance.
Candidates with backgrounds in pharmacy, life sciences, or clinical research can apply for this role. The position involves supporting global clinical trials by maintaining accurate documentation, performing quality checks, and ensuring compliance with ICH-GCP guidelines and regulatory standards.
This role provides an excellent entry point into clinical operations and TMF management, offering exposure to international clinical research projects and advanced documentation systems. Clinical Document Specialist Freshers Job at TransPerfect
Job Overview
| Parameter | Details |
|---|---|
| Job Title | Clinical Document Specialist |
| Company | TransPerfect |
| Industry | Clinical Research / CRO |
| Job Location | Pune, Maharashtra, India |
| Employment Type | Full-Time |
| Experience | 0 – 2 Years |
| Qualification | B.Pharm, M.Pharm, Pharm.D, BSc, MSc, Life Sciences, Clinical Research |
| Work Mode | Work From Office |
| Shift Timing | 9:30 AM – 6:30 PM |
| Number of Openings | 10 |
Company Overview
TransPerfect is a global company that provides language services, regulatory support, and clinical research solutions to organizations across industries including pharmaceuticals, biotechnology, healthcare, and technology.
The company supports clinical trials by offering services such as clinical document management, translation services, regulatory documentation, and data support for global clinical studies. TransPerfect collaborates with pharmaceutical companies and Contract Research Organizations (CROs) to ensure clinical trial documentation meets international regulatory requirements.
Working at TransPerfect provides professionals with exposure to global clinical trials, regulatory compliance processes, and electronic documentation systems used in clinical research. Clinical Document Specialist Freshers Job at TransPerfect
Job Location & Employment Type
Work Location:
Pune, Maharashtra, India
Employment Type:
Full-Time
Work Mode:
Work From Office
Shift Timing:
9:30 AM – 6:30 PM
Selected candidates will work within the clinical documentation and Trial Master File management teams.
Role Overview
The Clinical Document Specialist plays a key role in managing documentation associated with clinical trials. The position focuses on maintaining Trial Master File (TMF) documents, performing quality checks, and ensuring documentation compliance with global regulatory standards.
This role requires strong attention to detail and the ability to manage documentation workflows within structured clinical research environments. Clinical Document Specialist Freshers Job at TransPerfect
Key Roles & Responsibilities
Clinical Documentation & TMF Management
Clinical Document Specialists are responsible for maintaining and organizing documentation related to clinical trials.
Responsibilities include:
- Performing first-level quality control checks on clinical trial documents
- Reviewing essential and non-essential TMF documents
- Indexing and filing documents within electronic Trial Master File (eTMF) systems
- Ensuring proper document classification and organization
Proper documentation ensures that clinical trial records remain accessible and compliant with regulatory requirements. Clinical Document Specialist Freshers Job at TransPerfect
Regulatory Compliance and Documentation
The role requires maintaining documentation according to global clinical research regulations.
Responsibilities include:
- Ensuring documents comply with ICH-GCP guidelines
- Maintaining documentation in accordance with regulatory standards
- Preparing documentation for inspections and audits
- Supporting regulatory compliance activities related to clinical trials
Maintaining compliant documentation is essential for successful regulatory inspections. Clinical Document Specialist Freshers Job at TransPerfect
Project Coordination
Clinical Document Specialists collaborate with multiple stakeholders during clinical studies.
Responsibilities include:
- Maintaining study trackers and documentation logs
- Coordinating with project teams and document management teams
- Addressing documentation queries and resolving issues
- Ensuring documentation workflows follow established procedures
Effective coordination ensures smooth documentation management during clinical trials. Clinical Document Specialist Freshers Job at TransPerfect
Process Improvement and System Support
The role may also involve supporting system improvements and operational enhancements.
Responsibilities include:
- Identifying operational challenges within documentation workflows
- Suggesting improvements for document management processes
- Supporting User Acceptance Testing (UAT) during system updates
- Ensuring productivity and quality metrics are maintained
These activities help improve operational efficiency in clinical documentation processes. Clinical Document Specialist Freshers Job at TransPerfect
Eligibility Criteria
Educational Qualification
Candidates applying for this role should possess a bachelor’s degree in one of the following fields:
- B.Pharm
- M.Pharm
- Pharm.D
- B.Sc or M.Sc in Life Sciences
- Clinical Research
- Other related life sciences disciplines
Candidates with pharmacy or life sciences backgrounds are preferred due to their understanding of clinical research processes. Clinical Document Specialist Freshers Job at TransPerfect
Experience Required
Applicants should have:
- 0 – 2 years of experience
Relevant experience may include:
- Clinical research
- Clinical data management
- Pharmacovigilance
- Regulatory submissions
- Medical writing
- Site management
- eClinical systems or CTMS platforms
Fresh graduates with strong interest in clinical research documentation may also be considered. Clinical Document Specialist Freshers Job at TransPerfect
Technical Knowledge Required
Candidates should possess basic understanding of clinical research and documentation systems.
Important knowledge areas include:
- Clinical trial phases and study processes
- ICH-GCP guidelines
- Trial Master File (TMF) documentation
- Electronic TMF (eTMF) systems
- Microsoft Office tools such as Word, Excel, and Outlook
Skills Required
Candidates applying for this role should have the following skills:
- Strong attention to detail
- Good written and verbal communication skills
- Ability to manage documentation timelines
- Organizational and record management skills
- Ability to work in team-based clinical project environments
- Willingness to learn new clinical technologies and systems
Salary & Benefits
Salary for the Clinical Document Specialist role will be as per company norms and may vary depending on candidate experience and qualifications.
Benefits of working with TransPerfect may include:
- Exposure to global clinical trials
- Experience with Trial Master File management systems
- Professional development in clinical documentation and operations
- Opportunity to work with international pharmaceutical and CRO clients
- Career growth opportunities within clinical operations and regulatory documentation
Selection Process
The hiring process may include the following stages:
- Resume submission and screening
- HR interview or screening call
- Technical interview related to clinical documentation and research knowledge
- Final selection and offer
Candidates may be evaluated on their understanding of clinical research processes and documentation management.
How to Apply
Interested candidates can apply for the Clinical Document Specialist position by sending their updated resume to the following email address:
Email:
hritik.kale@transperfect.com
Applicants should ensure their resume highlights:
- Educational qualifications in pharmacy or life sciences
- Clinical research or documentation experience
- Knowledge of TMF or regulatory documentation
- Technical skills related to clinical systems
Why Apply for This Job?
This role provides a strong foundation for professionals interested in clinical research operations. Clinical Document Specialist Freshers Job at TransPerfect
Key advantages include:
- Exposure to international clinical trials and documentation processes
- Experience working with Trial Master File systems
- Opportunity to develop expertise in clinical operations and regulatory compliance
- Structured learning opportunities within a global organization
- Career progression opportunities in clinical research roles
This role can lead to advanced positions such as:
- Clinical Trial Associate
- TMF Specialist
- Clinical Operations Associate
- Clinical Data Manager
- Regulatory Affairs Specialist
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that publishes pharmaceutical and clinical research job opportunities for informational purposes only. We are not affiliated with TransPerfect or any recruitment agencies.
Candidates should apply directly through the official contact information provided. Applicants are advised not to pay any recruitment or placement fees to individuals or agencies. Clinical Document Specialist Freshers Job at TransPerfect
Final Call-to-Action
If you are a pharmacy or life sciences graduate looking to start your career in clinical research documentation and TMF management, this opportunity at TransPerfect could be an excellent starting point. Interested candidates should submit their updated resumes and take the next step toward building a career in clinical operations and clinical trial documentation. Clinical Document Specialist Freshers Job at TransPerfect
