Senior Project Manager; Veeva Vault Implementation

We are seeking a seasoned, GxP-focused IT/Clinical Project Manager to lead the end-to-end implementation and integration of the Veeva Vault suite (CTMS, eTMF, and QMS). You will bridge the gap between technical IT teams and business stakeholders, ensuring system architecture meets clinical and regulatory requirements, driving adoption, and ensuring inspection readiness.

Project & Implementation Management

• Lead the end-to-end implementation lifecycle (initiation, design, configuration, testing, validation, deployment, and hypercare) for Veeva Vault CTMS, eTMF, and QMS modules.
• Manage project timelines, budgets, and resource allocation, proactively identifying risks and escalating with actionable mitigation strategies.
• Facilitate workshops with Business Process Owners (BPOs) to map current processes against Veeva best practices and identify areas for system optimization.

Solution Design & Integration

• Act as a Subject Matter Expert (SME) on Veeva Vault functional capabilities, advising on back-end configuration implications and downstream system impacts.
• Oversee cross-platform integrations to ensure seamless end-to-end workflows between clinical operations and quality management systems.
• Review technical and functional documentation—including business requirements, validation plans, and SOPs—to ensure alignment with intended business outcomes.

Governance, Compliance & Inspection Readiness

• Ensure the implemented systems meet all 21 CFR Part 11 and GxP compliance requirements.
• Establish strong change control, data governance, and release lifecycle management processes.
• Design the systems with an "inspection-ready" framework, ensuring robust audit trails and document traceability.

Change Management & Stakeholder Enablement

• Serve as the primary translator between technical implementation teams and global business end-users.
• Develop and coordinate change management strategies, including stakeholder communication plans, training materials, and release announcements.
• Lead user adoption activities and post-go-live hypercare support models to ensure high user engagement and operational continuity.

Qualifications & Requirements

• Education: Bachelor’s degree in Life Sciences, Information Technology, or a related field. PMP certification is highly preferred.
• Experience: 5+ years of direct project management or consulting experience in the life sciences industry (Pharma, Biotech, or CRO).
• Veeva Expertise: Deep, proven expertise with Veeva Vault Clinical (CTMS/eTMF) and Veeva Vault QMS. Familiarity with back-end configuration, life cycles, and metadata.
• Regulatory Knowledge: Solid understanding of GxP guidelines, ICH-GCP, and 21 CFR Part 11.
• Soft Skills: Excellent communication and presentation skills; proven ability to manage multiple complex, matrixed work streams across global teams.