Are you looking to advance your career in the clinical research industry? Ora, a global leader in ophthalmic drug and device development, is currently hiring for the position of Clinical Document Management Specialist I (CDMS I) in Hyderabad. 🚀
This is a fantastic opportunity for professionals who are passionate about data integrity, quality oversight, and the future of healthcare. With more than 45 years of experience and over 85 product approvals, Ora provides a world-class environment to build expertise in eTMF management and clinical operations.
About Ora: Leading the Way in Ophthalmology 🌍
Ora is not just another CRO — it is recognized as one of the world’s leading full-service ophthalmic clinical research organizations. The company focuses on accelerating the development of innovative eye-care therapies and medical devices.
With a global workforce of more than 600 employees, Ora operates with strong values centered around:
- Prioritizing Kindness 🤝
- Operational Excellence 📈
- Scientific Rigor 🔬
- Continuous Learning 🌱
Their mission is to help bring life-changing ophthalmic treatments to patients faster and more efficiently.
Role Overview: Clinical Document Management Specialist I 📋
As a Clinical Document Management Specialist I, you will play a critical role in maintaining the integrity and compliance of clinical trial documentation.
The primary responsibility revolves around managing the electronic Trial Master File (eTMF) throughout the study lifecycle — from study start-up to final archiving.
Key Responsibilities 📝
- Manage and maintain documents within the Veeva Vault eTMF platform
- Conduct detailed Quality Control (QC) reviews of clinical and regulatory documents
- Ensure compliance with ICH GCP, FDA regulations, and EU directives
- Collaborate with Clinical Operations, QA, Biometrics, and project teams
- Support TMF close-out and archival activities
- Generate reports and track TMF completeness metrics
- Ensure all documents remain inspection-ready at all times
Eligibility Criteria 🎓
Education & Experience
- Bachelor’s Degree in a relevant field
- At least 1 year of training or work experience in clinical research, healthcare, or medical documentation
- Equivalent relevant experience may also be considered
Preferred Skills & Knowledge 💡
- Experience as a Clinical Trial Associate (CTA) or Study Coordinator
- Hands-on experience with Veeva Vault (highly preferred)
- Knowledge of ALCOA+ principles
- Understanding of TMF Reference Model and ICH GCP guidelines
- Strong written and verbal communication skills
Why Join Ora? 🌈
Ora promotes a unique workplace culture called the “Daily Practice of Joy.” The company values employees with strong:
- IQ (Intellectual Curiosity) 🧠
- EQ (Emotional Intelligence) ❤️
- SQ (Social Curiosity) 🌍
Benefits of Working at Ora
- Growth-oriented work environment
- Exposure to global clinical projects
- Strong mentorship and leadership visibility
- Collaborative and psychologically safe workplace
- Opportunity to contribute to life-changing ophthalmic innovations
How to Apply 📲
If you are interested in building a career in clinical operations and document management, this opportunity could be a strong next step.
Apply Here 👇🏻
LinkedIn Job Application – Clinical Document Management Specialist I at Ora
Before applying, make sure your resume highlights:
- Clinical documentation experience
- Knowledge of regulatory guidelines
- Experience with eTMF systems or Veeva Vault
- Attention to detail and compliance management skills
Conclusion ✨
The Clinical Document Management Specialist I role at Ora offers an excellent opportunity to grow within the clinical research and pharmaceutical industry. By managing accurate and compliant trial documentation, you become an essential part of bringing innovative ophthalmic treatments to patients worldwide. 🌍👁️
If you are passionate about clinical quality, compliance, and healthcare innovation, this could be the perfect opportunity to elevate your career.
Candidates interested in pharmacovigilance, medical writing, and regulatory affairs opportunities can also explore other pharma openings available for pharmacy graduates and freshers.
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