Job Description

Project Role :

Software Development Lead

Project Role Description :

Develop and configure software systems either end-to-end or for a specific stage of product lifecycle. Apply knowledge of technologies, applications, methodologies, processes and tools to support a client, project or entity.

Must have skills :

Veeva Vault

Good to have skills :

NA

Minimum

5

year(s) of experience is required

Educational Qualification :

15 years full time education



Summary: We are seeking a highly experienced and strategic Veeva Vault Clinical Development Lead to manage, lead, and deliver Veeva Vault-based solutions for clinical operations. The ideal candidate will have 5+ years of IT experience with significant hands-on and leadership experience in the Life Sciences domain, specifically in implementing and supporting Veeva Vault Clinical Suite (eTMF, CTMS, Study Startup, Site Connect, etc.). The role involves cross-functional leadership, stakeholder engagement, vendor coordination, and end-to-end solution delivery in regulated environments. The candidate must bring a deep understanding of clinical trial processes, GxP compliance, and Veeva platform capabilities. Roles & Responsibilities: - Lead end-to-end implementation and management of Veeva Vault Clinical Suite solutions (eTMF, CTMS, Study Startup, etc.). - Serve as the primary point of contact for business stakeholders, ensuring alignment of IT solutions with clinical operational needs. - Manage cross-functional project teams, including business analysts, developers and testers. - Define and drive project plans, timelines, and deliverables, ensuring on-time and within-budget execution. - Oversee system configuration, customization, validation, and deployment in alignment with GxP and 21 CFR Part 11 compliance requirements. - Facilitate requirement gathering, gap analysis, and solution design for clinical operations use cases. - Provide strategic guidance and roadmap planning for Veeva Vault Clinical implementations and enhancements. - Lead and support validation activities including creation and review of validation documentation (URS, IQ/OQ/PQ, test scripts). - Maintain awareness of industry trends, Veeva releases, and regulatory changes impacting clinical systems. Professional & Technical Skills: - Familiarity with GxP, GDPR, 21 CFR Part 11, and validation requirements. - Prior experience in a regulated pharmaceutical or CRO environment. - Ability to work across time zones with global teams. Additional Information: - The candidate should have minimum 5 years of experience in Veeva Vault. - This position is based at our Bengaluru office. - A 15 years full time education is required.




15 years full time education