Ora Clinical Research Careers is inviting applications for the position of Clinical Document Management Specialist I in Hyderabad, Telangana, India. This is an excellent opportunity for candidates with experience in clinical research, TMF management, clinical operations, or study coordination who want to build a long-term career in clinical document management and eTMF operations.
The role focuses on managing and maintaining electronic Trial Master Files (eTMF), ensuring inspection readiness, supporting quality control of clinical documents, and maintaining compliance with ICH-GCP and regulatory requirements. Candidates with exposure to Veeva Vault, ALCOA+ principles, and clinical trial documentation will have an added advantage.
With more than 45 years of expertise in ophthalmic clinical research, Ora Clinical has supported over 85 product approvals globally and continues expanding its operations across multiple regions.
Job Overview
| Job Details | Information |
|---|---|
| Job Role | Clinical Document Management Specialist I |
| Company | Ora Clinical |
| Location | Hyderabad |
| Department | Clinical Document Management |
| Job Type | Full-Time |
| Experience Required | Minimum 1 Year |
| Qualification | Bachelor’s Degree in Life Sciences, Pharmacy, Medical, or Research Field |
| Preferred Skills | eTMF, Veeva Vault, TMF Management, Clinical Documentation |
| Mode of Work | On-site (3–5 days/week) |
Key Responsibilities
The selected candidate will support clinical trial documentation management activities and ensure regulatory compliance throughout the study lifecycle.
Primary Responsibilities
- Manage electronic Trial Master File (eTMF) documentation using Veeva Vault
- Perform quality control (QC) review of clinical and regulatory documents
- Ensure documents are filed accurately and within timelines
- Support inspection readiness and TMF compliance activities
- Collaborate with clinical operations, QA, biometrics, and monitoring teams
- Generate metrics reports for completeness review
- Assist with study close-out and archival activities
- Support corrective action plans related to TMF management
- Maintain compliance with SOPs, ICH-GCP guidelines, FDA, and EU regulations
Required Qualifications
Educational Qualification
- Bachelor’s Degree in:
- Pharmacy
- Life Sciences
- Medical Sciences
- Clinical Research
- Biotechnology
- Related healthcare or research disciplines
Experience Requirements
- Minimum 1 year of training or work experience in:
- Clinical Research
- Clinical Operations
- Clinical Documentation Management
- TMF/eTMF Management
Preferred Candidate Profile
Candidates with the following experience are strongly preferred:
- Clinical Trial Associate (CTA)
- Study Coordinator / Clinical Research Coordinator
- Regulatory Documentation Support
- Trial Master File (TMF) Management
- Quality Control of Clinical Documents
- Experience with Veeva Vault
- Understanding of ALCOA+ principles
- Familiarity with ICH-GCP guidelines
Skills Required
- Strong attention to detail
- Excellent document organization skills
- Good written and verbal communication
- Ability to meet deadlines and manage priorities
- Collaboration and teamwork abilities
- Adaptability and process-oriented mindset
- Knowledge of clinical trial documentation systems
Why Join Ora?
Ora Clinical offers a collaborative and inclusive work environment focused on innovation in ophthalmology and clinical development.
Employee Benefits
- Global exposure in ophthalmic clinical research
- Career growth in clinical document management
- Opportunity to work with advanced eTMF systems
- Inclusive and diverse workplace culture
- Learning-focused environment with operational excellence
- Exposure to international regulatory standards