JOB DESCRIPTION
Job title
Clinical Systems Analyst
Reports to
Director of Data Management and Programming

Job purpose
The Clinical Systems Analyst serves as a subject matter expert and supports as liaison between Data Management and clinical study teams, IT, vendors, and external partners to ensure effective implementation, validation, optimization, and support of clinical trial systems. This role supports the end-to-end lifecycle of GxP computerized systems used in clinical research and ensures compliance with regulatory requirements while enabling effective, high‑quality clinical data collection and review.
Hands on experience of Data management Data Management activities including but not limited to clinical database design, CRF development, Data monitoring, Validation, Randomization, study design and integration between EDC, CTMS, RTSM and TMF required in support of study conduct per protocol.
Senior Clinical data Analyst will mentor Junior staff.

Duties and responsibilities
- Clinical Systems Leadership & Support
- Performs analysis, implementation, configuration,



and ongoing support of clinical systems, including but not limited to EDC, eCOA, RTSM, CTMS, eTMF, safety interfaces.
- Act as the point of contact for Study design and system-related inquiries from clinical operations, data management, biostatistics, safety, and medical writing teams.
- Provide guidance on system capabilities, limitations, and best practices to support study execution.
- Requirements & Solution Design
- Partner with business stakeholders to gather, analyze, and translate the study Data Manager requirements into functional and technical specifications.
- Support the Data manager with the following
- Design, Update CRF per protocol
- Automate or support data monitoring and cleaning activities
- Edit check
- Implementation of study in RTSM, CTMS, EDC, ETMF per protocol
- Data Management plan
- Data Dictionaries
- Data transfer specifications
- Support vendor selection and system evalu

📌 Clinical Systems Analyst (Hyderabad)
🏢 Ocugen India Private
📍 Hyderabad