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.
