Clinical Systems Analyst
Director of Data Management and Programming

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 productive, 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.

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.
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
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
Contribute to solution design decisions that align with business needs, regulatory expectations, and data standards.
Support and/or lead computer system validation (CSV/CSA) activities in compliance with 21 CFR Part 11, FDA, ICH GCP, CDISC , ALCOA++, and GAMP 5 principles.
Configuration Workbooks
User Acceptanc

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