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 efficient, 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 RFP participation, demos, and fit-gap assessments.
Contribute to solution design decisions that align with business needs, regulatory expectations, and data standards.
Validation & Compliance (GxP)
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.
Develop, review, and maintain validation deliverables such as:
System user access management
System Impact Assessments
Configuration Workbooks
Test Plans and Test Scripts
Traceability Matrices
User Acceptance Testing (UAT) documentation
Ensure systems remain inspection ready throughout the study lifecycle.
Risk mitigation strategy and monitoring during stud lifecycle
Testing, Training & Change Management
Execute system testing and UAT, coordinating with cross-functional stakeholders and vendors.
Develop end-user training materials, conduct training sessions, and support system adoption across study teams.
Manage system change requests, enhancements, and defect resolution following controlled change management processes.
Cross Functional Collaboration & Governance
Collaborate closely with Clinical Operations, Data Management, Biostatistics, Safety, IT, Quality, and external vendors.
Supports governance forums for clinical systems, contributing to roadmaps, standards, and continuous improvement initiatives.
Serve as a knowledge resource within the clinical systems function.
Provide end-to-end study protocol
Supports Audit,



Inspection readiness activities from Data management
Take on projects and activities assigned by the cross functional teams and management
Qualifications
Bachelor’s degree in Life Sciences, Computer Science, Engineering, or related field required.
5+ years of experience supporting clinical trial systems within a Data Management group of a pharma or biotech GxP environment .
Hands-on experience with Veeva Clinical Systems and end-to-end eClinical processes; experience with any of Veeva CTMS, eTMF, EDC, or RTSM preferred.
Strong understanding of clinical trial processes , including EDC setup, external data integrations, clinical data review, and submission readiness.
Knowledge of regulatory and compliance requirements (21 CFR Part 11, ICH, GAMP 5).
Preferred Qualifications
Experience with clinical data warehouses or advanced data review platforms .
Familiarity with SDTM/ADaM concepts , external data reconciliation, and downstream use of clinical data.
Prior experience supporting regulatory Submissions, inspections or audits.
Project team experience in a matrixed, cross functional environment .
Key Skills & Competencies
Excellent analytical and problem-solving skills.
Strong written and verbal communication skills with the ability to translate technical concepts to non‑technical stakeholders.
Ability to manage multiple priorities in a fast-paced clinical development environment.
High attention to detail with a quality‑ and compliance focused mindset.
Cooperative, proactive, and solution-oriented approach.
Self-motivated with a proven track record of high quality, on-time deliverables.
Working Conditions
This position operates in an office setting, in person.
Job may additionally require incumbent to be available outside of these hours to handle priority business needs.
Physical Requirements
This is a largely sedentary role.
Direct Reports
N/A

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