Custom Software Engineer

Project Role :Custom Software Engineer

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 10+ 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.

Strong understanding of clinical development processes, clinical trial lifecycle, and regulatory compliance.

Hands-on knowledge of Veeva Vault configuration, workflows, security, and integration best practices.

Experience working with Agile/Waterfall methodologies and validated system delivery.

Excellent stakeholder management, communication, and leadership skills. Veeva certification(s) is a plus.

Experience with integration tools, data migration, and API interactions is an advantage.

Additional Information:

10+ years of IT experience, with at least 5-6 years of hands-on experience in Veeva Vault Clinical applications.

Proven experience leading large-scale Veeva Vault Clinical projects, preferably in global life sciences environments.

A 15 years full time education is required.

Qualification
15 years full time education