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A promising opportunity is now open for a Clinical Trial Associate (CTA) eTMF Specialist in Hyderabad with Ocugen. This role is ideal for candidates with experience in clinical research, eTMF management, and clinical operations who want to grow in global clinical trials.
If you have hands-on exposure to TMF, ICH-GCP, CRO/vendor management, and clinical trial documentation, this position offers strong career progression in the clinical research domain.
๐ Job Overview
- Role: Clinical Trial Associate โ eTMF Specialist
- Location: Hyderabad, Telangana (On-site)
- Experience: 1+ years
- Industry: Clinical Research / Biotechnology / CRO
- Employment Type: Full-time
๐ Key Responsibilities
As a Clinical Trial Associate eTMF Specialist, you will:
- Manage eTMF (electronic Trial Master File) from study startup to closeout
- Ensure TMF is audit-ready and compliant with ICH-GCP and regulatory standards
- Coordinate with cross-functional teams to collect and maintain clinical documents
- Support clinical study execution within timelines and budgets
- Contribute to:
- Study protocols
- Case Report Forms (CRFs)
- Clinical Study Reports (CSR)
- Informed Consent Forms (ICF)
- Oversee site initiation, monitoring, and closure activities with CRAs
- Participate in CRO/vendor selection and management (RFI/RFP process)
- Track study progress, risks, and timelines
- Ensure data integrity, patient safety, and regulatory compliance
- Assist in audit preparation and SOP development
- Provide updates to senior management
๐ฏ Required Qualifications
Educational Requirements
- Bachelorโs degree (B.Pharm / Life Sciences preferred)
Experience
- Minimum 1+ years in clinical research or clinical trials
- Experience in:
- eTMF management
- CRO/vendor management
- Clinical documentation and operations
Technical Skills
- Strong knowledge of:
- ICH-GCP guidelines
- FDA regulations
- Hands-on experience with:
- eTMF systems
- CTMS, EDC, RTSM
- Veeva (preferred)
Additional Skills
- Strong organizational and communication skills
- Attention to detail
- Ability to manage timelines and resolve issues
โญ Preferred Experience
- Exposure to Phase IโIII clinical trials
- Experience in Ophthalmology or advanced therapy studies
- Audit readiness and TMF reconciliation experience
๐ผ Benefits & Career Growth
- Work with a global biotech organization
- Exposure to end-to-end clinical trial lifecycle
- Opportunity to work on international regulatory submissions
- Strong career path in:
- Clinical Operations
- Clinical Project Management
- eTMF & Trial Master File specialization
๐ฉ How to Apply
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