We are looking for a proactive and detail-oriented
CSV Executive
to support software validation and clinical trial systems (CTMS) activities. The role involves software testing, validation execution, documentation, and data quality monitoring to ensure compliance with regulatory and operational standards.
Key Responsibilities
Execute Computer System Validation (CSV) activities for CTMS systems.
Conduct software testing for each deployment and verify compliance with URS/FRS.
Prepare and update SOPs related to CTMS operations.
Perform IQ/OQ/PQ for CTMS systems and validate all new deployments.
Design eCRFs, user requirements, edit checks, and data validation logic.
Create, validate, and maintain project documentation in compliance with regulatory guidelines.
Monitor and resolve data queries; ensure clinical data quality in EDC systems.
Support database lock/unlock, freeze/unfreeze activities for interim and final reviews.
Coordinate with Clinical Trial Monitors and manage CDM (Clinical Data Management) activities.
Participate in project calls and meetings with internal and external stakeholders or vendors.
Support instrument interfacing and procurement master creation based on software requirements.
Train or mentor junior team members as needed.
Perform other duties assigned by the Section Head or Head of Operations.
Requirements
6 months to 1 year of relevant experience in CSV / Software Testing / Clinical Data Management.
Knowledge of CTMS systems, EDC platforms, and validation standards.
Familiarity with GxP, 21 CFR Part 11, and regulatory compliance in clinical systems.
Strong documentation and communication skills.
Detail-oriented with good problem-solving abilities.
Ability to work independently as well as in a team environment.
If you'd like, I can also create:
A concise LinkedIn post version
An eye-catching WhatsApp/Telegram message
A JD flyer or infographic text
Job Type: Full-time
Work Location: In person
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