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We're Nagarro:
We are a Digital Product Engineering company that is scaling in a big way! We build products, services, and experiences that inspire, excite, and delight. We work at scale across all devices and digital mediums, and our people exist everywhere in the world (17,500+ experts across 39 countries, to be exact). Our work culture is dynamic and non-hierarchical. We're looking for great new colleagues. That's where you come in!
REQUIREMENTS:
Total experience: 10+ years
- Strong expertise in Medidata ecosystem (REVA EDC) with hands-on configuration and implementation experience.
- Familiarity with Regulatory Affairs, Quality Management, and Life Sciences domain processes.
- Solid understanding of SDLC, Agile, ITIL, and GxP validation methodologies.
- Ability to create BRD, FRS, and validation documentation (IQ/OQ/PQ).
- Proficient in tools like Excel, Power BI, Jira, Visio, Miro, Lucid Charts.
- Excellent communication and stakeholder management skills.
- Medidata tool experience is mandatory; Veeva knowledge is a plus.
- ITIL or Agile (Scrum Master / SAFe) certification preferred.
RESPONSIBILITIES:
- Act as the primary liaison between business stakeholders and technical teams to capture and translate requirements.
- Conduct requirement workshops, impact assessments, and functional design reviews for Medidata Vault modules.
- Support Medidata Vault configuration governance, UAT, and validation activities.
- Coordinate integration and migration activities across connected systems (CRM, RIM, QMS, ERP).
- Maintain traceability across user stories, test cases, and validation deliverables in compliance with SDLC and CSV standards.
- Prepare project plans, RAID logs, and dashboards for leadership reporting.
- Facilitate cross-functional collaboration with vendors and client SMEs.
- Conduct training sessions for business users on new Vault capabilities.
- Ensure compliance with GxP, 21 CFR Part 11, and audit requirements.
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