Novotech hiring Clinical Document Specialist in Bangalore. Apply for TMF management role with ICH GCP and clinical documentation experience required.
Introduction
Candidates looking to build a strong career in clinical documentation and Trial Master File (TMF) management can explore this opportunity. Novotech is hiring a Clinical Document Specialist in Bangalore. This role is ideal for professionals interested in clinical operations, compliance, and document quality management within global clinical trials.
Company Overview
Novotech is a leading international contract research organization (CRO) providing clinical development services to pharmaceutical and biotechnology companies worldwide. Known for its expertise in clinical trials and regulatory compliance, Novotech supports global drug development with high-quality research and operational excellence.
Job Location & Employment Type
- Location: Bangalore, Karnataka, India
- Workplace: Helios Business Park
- Job Type: Full-Time
- Industry: Clinical Research / TMF / Document Management
Job Overview (Job Details Table)
| Job Title | Clinical Document Specialist (CDS) |
|---|---|
| Company Name | Novotech |
| Qualification | Life Sciences / Pharmacy / Related Field |
| Experience | Relevant experience preferred |
| Job Location | Bangalore, Karnataka |
| Employment Type | Full-Time |
| Salary | As per company norms |
| Application Mode | Online Application |
| Department | Clinical Operations / TMF |
| Job ID | 3829 |
Open Positions / Department Details
This role is part of the Clinical Operations and Document Management Team, focusing on the management and quality maintenance of Trial Master Files (TMF). The position supports multiple clinical projects and ensures documentation compliance with global standards.
Key Roles & Responsibilities
As a Clinical Document Specialist, your responsibilities will include:
- Supporting Trial Master File (TMF) activities for assigned clinical studies
- Managing both electronic and paper-based TMF systems
- Setting up and maintaining TMF structures for clinical trials
- Ensuring documentation quality, completeness, and accuracy
- Maintaining essential clinical trial documents as per requirements
- Ensuring compliance with:
- ICH GCP guidelines
- Local and global regulatory requirements
- Company and client SOPs
- Coordinating with internal clinical teams and external stakeholders
- Supporting audits and inspections related to TMF
- Monitoring document workflows and ensuring timely updates
Eligibility Criteria
Educational Qualification
- Degree in:
- Life Sciences
- Pharmacy
- Biotechnology
- Related discipline
Experience Required
- Relevant experience in:
- Clinical research
- TMF/document management
- Clinical operations (preferred)
Skills Required
- Knowledge of Trial Master File (TMF) processes
- Understanding of ICH GCP guidelines
- Strong documentation and organizational skills
- High attention to detail and quality standards
- Ability to manage multiple projects and timelines
- Good communication and coordination skills
- Familiarity with electronic document management systems (EDMS)
Salary & Benefits
- Salary: As per company norms
- Opportunity to work with a global CRO (Novotech)
- Exposure to international clinical trial documentation practices
- Career growth in clinical operations and documentation management
- Collaborative and professional work environment
Selection Process
The recruitment process may include:
- Application Screening
- Technical/Functional Interview
- HR Discussion
- Final Selection
Candidates with TMF and clinical documentation experience will be preferred.
How to Apply
Interested candidates can apply through the official Novotech career portal using the job details below:
- Job ID: 3829
Ensure your resume highlights:
- TMF/document management experience
- Knowledge of ICH GCP
- Clinical research exposure
Important Dates
- Last Date to Apply: April 29, 2026
Why Apply for This Pharma Job?
This role offers strong career growth for candidates interested in clinical documentation:
- Work with a global CRO environment
- Gain expertise in TMF and clinical compliance systems
- Exposure to global regulatory standards
- Opportunity to grow into clinical operations and project roles
- Build a long-term career in clinical research documentation
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with any company or recruiter. Candidates are advised to verify all details independently before applying. We do not charge any fee for job applications.
Final Call-to-Action
If you are interested in clinical documentation and TMF management, apply before the deadline. This Novotech opportunity in Bangalore can help you build a strong career in clinical operations and regulatory compliance.
