Role & responsibilities

Act as Clinical Subject Matter Expert (SME) bridging clinical, regulatory, and technology teams across the clinical Trial Lifecycle.

- Elicit, analyze, and document business and functional requirements (BRDs, FRDs, user stories with acceptance criteria) for clinical trial systems and data solutions.
- Map current-state and future-state clinical processes (study startup, site management, patient recruitment, data collection, safety reporting, database lock, study closeout) and identify gaps and improvement opportunities.
- Provide domain guidance on Phase IIV clinical trials, protocol design impacts, and study-level data flows to development, data, and QA teams.
- Support configuration and implementation of clinical platforms such as CTMS, EDC (Medidata Rave, Veeva CDMS), RTSM/IWRS, ePRO/eCOA, eTMF, and safety/pharmacovigilance systems.
- Define data requirements, mapping specifications,



and integration needs across clinical systems, including alignment with CDISC standards (CDASH, SDTM, ADaM).
- Plan and lead UAT: author test scenarios and scripts, coordinate business testers, triage defects, and support Computer System Validation (CSV) documentation.
- Ensure solutions comply with ICH-GCP, 21 CFR Part 11, EU Annex 11, GDPR/HIPAA, and applicable regulatory guidelines.
- Work closely with sponsors, CROs, sites, product owners, and vendors to prioritize the backlog, manage scope, and drive stakeholder sign-off.
- Contribute to pre-sales and business development: solution design, requirement workshops, effort estimation, proposal content, and client demos.
- Create training materials, SOP updates, and change management content to drive user adoption.

📌 Parex - Clinical SME (Chennai)
🏢 Hexaware Technologies
📍 Chennai