Clinical Document Management Specialist I

🚀 WE’RE HIRING – Clinical Document Management Specialist I | Ora Clinical Research 🚀

Looking to build your career in Clinical Research, TMF/eTMF Management, Clinical Operations, and Regulatory Documentation? Ora Clinical Research is hiring for the role of Clinical Document Management Specialist I in Hyderabad. 📂💊

This is an excellent opportunity for professionals with experience in clinical trial documentation, TMF management, Veeva Vault, inspection readiness, and regulatory compliance who want to grow in the clinical research and document management domain.

🏢 Company: Ora Clinical
🌐 Website: https://oraclinical.com/

👉 Role: Clinical Document Management Specialist I
👉 Experience: Minimum 1 Year
📍 Location: Hyderabad, Telangana
💼 Job Type: Full-Time
🏢 Work Mode: Onsite (3–5 Days/Week)
🏭 Department: Clinical Document Management
🏢 Industry: Clinical Research / Clinical Operations / eTMF Management

📌 About the Company:
Ora Clinical Research is a globally recognized clinical research organization specializing in ophthalmic clinical development. With more than 45 years of expertise, Ora has supported over 85 product approvals worldwide and continues to expand its global operations across multiple therapeutic and regulatory landscapes.

The organization is known for innovation, operational excellence, clinical quality, and strong expertise in ophthalmology-focused clinical trials and regulatory compliance.

📋 Job Overview:
The Clinical Document Management Specialist I role focuses on managing and maintaining electronic Trial Master Files (eTMF), supporting inspection readiness, performing quality checks on clinical documentation, and ensuring compliance with ICH-GCP and regulatory standards.

Candidates with exposure to Veeva Vault, ALCOA+ principles, clinical documentation workflows, and TMF quality control activities will have a strong advantage.

🎓 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

🔧 Key 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 defined timelines
• Support inspection readiness and TMF compliance activities
• Collaborate with Clinical Operations, QA, Biometrics, and Monitoring teams
• Generate metrics reports for TMF completeness and quality review
• Assist in study close-out and archival activities
• Support corrective and preventive action plans related to TMF management
• Maintain compliance with SOPs, ICH-GCP guidelines, FDA, and EU regulations
• Ensure proper document version control and audit readiness throughout study lifecycle

🎯 Preferred Candidate Profile:
Candidates with experience in the following areas are strongly preferred:

• Clinical Trial Associate (CTA) activities
• Study Coordinator / Clinical Research Coordinator responsibilities
• Regulatory documentation support
• Trial Master File (TMF) management
• Quality control review of clinical documents
• Experience with Veeva Vault systems
• Understanding of ALCOA+ principles
• Familiarity with ICH-GCP guidelines and regulatory standards

💡 Required Skills:
• Strong attention to detail and documentation accuracy
• Excellent document organization and tracking skills
• Good written and verbal communication abilities
• Ability to manage deadlines and multiple priorities
• Strong collaboration and teamwork mindset
• Process-oriented and adaptable working style
• Understanding of clinical trial documentation systems and workflows

✨ Why Join Ora Clinical?
• Opportunity to work with a globally recognized ophthalmic CRO
• Exposure to advanced eTMF systems and global clinical operations
• Career growth opportunities in Clinical Document Management
• Inclusive and collaborative work culture
• Learning-focused environment with operational excellence
• Exposure to international regulatory standards and inspection readiness activities
• Opportunity to work on global ophthalmology clinical trials and product development programs

💬 Join WhatsApp Group:
Join Now

⚡ Take your Clinical Research and eTMF career to the next level with Ora Clinical — where clinical documentation quality meets global research excellence!