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 evaluation activities, including RF

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