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Ora Clinical Hiring Clinical Document Management Specialist I in Hyderabad 2026 | eTMF & Veeva Vault Jobs
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Ora Clinical Hiring Clinical Document Management Specialist I in Hyderabad 2026
The clinical research industry in India is growing rapidly with increasing demand for professionals skilled in Trial Master File (TMF) management, eTMF operations, and clinical documentation compliance. Ora Clinical Research Careers has announced a new opportunity for the role of Clinical Document Management Specialist I in Hyderabad, Telangana.
This role is ideal for candidates with experience in clinical research, clinical operations, TMF management, study coordination, and regulatory documentation. Professionals looking to build long-term careers in clinical document management and electronic Trial Master File systems can benefit significantly from this opportunity.
Candidates with knowledge of Veeva Vault, ALCOA+ principles, ICH-GCP guidelines, and regulatory compliance standards will have an added advantage during the selection process.
About Ora Clinical
Ora Clinical is a globally recognized ophthalmic clinical research organization with more than 45 years of expertise in ophthalmology-focused clinical development and regulatory research services.
The company specializes in supporting pharmaceutical, biotechnology, and medical device organizations in ophthalmic product development, clinical trial execution, regulatory compliance, and clinical operations management.
Headquartered in Massachusetts, United States, Ora has supported more than 85 product approvals globally and continues expanding its clinical research services across multiple international markets.
Ora Clinical is known for maintaining high operational standards, advanced clinical technologies, a collaborative work culture, and strong expertise in regulatory and quality compliance systems.
The organization offers employees opportunities for global exposure, clinical operations growth, and experience with advanced eTMF and clinical documentation platforms.
Job Overview Summary
Ora Clinical is hiring Clinical Document Management Specialist I professionals for its Hyderabad office. The selected candidate will support eTMF management activities, document quality review, regulatory compliance, and clinical trial documentation processes.
The role involves working with Veeva Vault systems, maintaining inspection readiness, supporting study close-out activities, and collaborating with multiple clinical research teams.
This opportunity is highly suitable for candidates interested in TMF management careers, clinical operations jobs, and regulatory documentation roles in the pharmaceutical and clinical research industry.
Vacancy Details
Particulars
Details
Job Role
Clinical Document Management Specialist I
Company
Ora Clinical
Location
Hyderabad, Telangana
Department
Clinical Document Management
Job Type
Full-Time
Experience Required
Minimum 1 Year
Qualification
Bachelor’s Degree
Preferred Skills
eTMF, TMF Management, Veeva Vault
Work Mode
On-site (3–5 days/week)
Job Role Explanation
The Clinical Document Management Specialist will support clinical trial documentation activities throughout the study lifecycle. The role focuses on maintaining electronic Trial Master Files, ensuring regulatory compliance, and supporting inspection readiness activities.
Professionals in this role will coordinate with clinical operations teams, quality assurance departments, biometrics teams, and monitoring staff to ensure proper filing and management of essential clinical trial documents.
Candidates will gain hands-on exposure to international regulatory standards, eTMF systems, clinical operations workflows, and document quality management processes.
Key Responsibilities of Clinical Document Management Specialist I
eTMF Management
The selected candidate will manage and maintain electronic Trial Master Files (eTMF) using Veeva Vault systems while ensuring proper document organization and filing accuracy.
Quality Control Review
Professionals will perform a QC review of regulatory and clinical trial documents to ensure compliance with SOPs and regulatory guidelines.
Inspection Readiness Support
The role includes supporting TMF inspection readiness activities and ensuring documentation completeness throughout the study lifecycle.
Collaboration with Clinical Teams
Candidates will collaborate with:
Clinical Operations Teams
Quality Assurance Departments
Biometrics Teams
Clinical Monitoring Teams
Regulatory Documentation Teams
Metrics & Reporting
The selected professional will assist in generating completeness review reports, metrics analysis, and study documentation tracking activities.
Study Close-Out Activities
Responsibilities also include supporting archival activities, TMF reconciliation, and corrective action planning during study closure.
Eligibility Criteria
Candidates applying for the Ora Clinical Document Management Specialist I role should possess:
Educational Qualification
Bachelor’s Degree in:
Pharmacy
Life Sciences
Medical Sciences
Biotechnology
Clinical Research
Related Healthcare Disciplines
Experience Requirements
Minimum 1 year of experience or training in:
Clinical Research
Clinical Operations
TMF/eTMF Management
Clinical Documentation Management
Study Coordination
Preferred Candidate Profile
Candidates with experience in the following areas are strongly preferred:
Clinical Trial Associate (CTA)
Clinical Research Coordinator (CRC)
Regulatory Documentation Support
Trial Master File Management
Veeva Vault Operations
Quality Control of Clinical Documents
ALCOA+ Principles
ICH-GCP Guidelines
Skills Required
Technical Skills
eTMF Management
Veeva Vault Handling
Clinical Documentation Review
TMF Compliance
Regulatory Filing Knowledge
Inspection Readiness Support
SOP Compliance
Quality Control Activities
Soft Skills
Strong attention to detail
Organizational abilities
Communication skills
Time management
Collaboration and teamwork
Process-oriented mindset
Adaptability and learning ability
Salary Estimate
Based on current clinical research and TMF management industry standards in India, the estimated salary for the Clinical Document Management Specialist I role at Ora Clinical is approximately:
Estimated Salary Range:
₹4.5 LPA – ₹7.5 LPA
The final salary package may vary depending on:
TMF management experience
Veeva Vault exposure
Clinical operations background
Interview performance
Regulatory documentation expertise
Why Join Ora Clinical?
Ora Clinical offers excellent opportunities for professionals interested in clinical operations and document management careers.
Employee Benefits
Exposure to global ophthalmic clinical trials
Career growth in clinical document management
Opportunity to work with advanced eTMF systems
Learning-focused work environment
International regulatory exposure
Inclusive and collaborative workplace culture
Professional development opportunities
Interview Details
Selection Process May Include:
Resume Shortlisting
HR Interview
Technical Clinical Documentation Round
TMF/eTMF Knowledge Assessment
Final Managerial Discussion
Candidates should prepare topics related to:
ICH-GCP Guidelines
ALCOA+ Principles
Trial Master File Structure
Veeva Vault
Clinical Trial Documentation
Inspection Readiness
SOP Compliance
Required Documents
Candidates should keep the following documents ready before applying:
Updated Resume/CV
Educational Certificates
Government ID Proof
Experience Certificates
Internship Certificates (if applicable)
Passport-size Photograph
Clinical Research Training Certificates
Job Location
Hyderabad, Telangana, India
Hyderabad is one of India’s leading pharmaceutical and clinical research hubs with excellent opportunities in:
Clinical Operations
Pharmacovigilance
TMF Management
Regulatory Affairs
Drug Safety
Clinical Data Management
How to Apply
Interested and eligible candidates can apply through the official application link below:
Ora Clinical is hiring for the position of Clinical Document Management Specialist I in Hyderabad.
Q2. What experience is required for this role?
Candidates should have a minimum of 1 year of experience or training in clinical research, TMF management, or clinical documentation.
Q3. Is Veeva Vault experience required?
Candidates with Veeva Vault experience are strongly preferred for this position.
Q4. What is the estimated salary for this role?
The estimated salary ranges between ₹4.5 LPA and ₹7.5 LPA, depending on experience and skills.
Q5. Who can apply for this clinical document management job?
Candidates from Pharmacy, Life Sciences, Biotechnology, Medical Sciences, and Clinical Research backgrounds can apply.
Q6. What are the major skills required?
Important skills include eTMF management, TMF compliance, Veeva Vault handling, clinical documentation review, and ICH-GCP knowledge.
Final Conclusion
The Ora Clinical Document Management Specialist I job in Hyderabad is an excellent opportunity for candidates looking to build strong careers in clinical documentation management and eTMF operations.
With increasing global demand for regulatory compliance, TMF management, and inspection-ready clinical documentation, professionals skilled in Veeva Vault and clinical operations are becoming highly valuable in the pharmaceutical and clinical research industry.
Candidates with clinical research experience, TMF knowledge, and strong documentation skills should apply early to secure this opportunity and gain international exposure in clinical operations and ophthalmic research.
Disclaimer
Note: Pharma Duniya does not charge any money for job information. Candidates are advised to verify details from the official company website.
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