Project Manager, Clinical Trial Capabilities, NextGen Clinical Systems

Project Manager, Clinical Trial Capabilities, Next Gen Clinical Systems support
Foster City, CA (Hybrid – 3 days onsite & 2 days remote)
Duration: 18 Months Contract + Possible Extensions

Role Summary
This role sits within the Clinical Trial Capabilities Business Support Model and is primarily responsible for end-to-end project management of:

• Vault Clinical operational setup and readiness, and
• Decommissioning of the legacy CTMS platform.

• Lead end-to-end planning and execution of Vault Clinical operational setup and existing CTMS decommissioning activities, ensuring alignment with programme timelines and milestones.
• Develop and maintain integrated project plans, including dependencies across system build, data migration, validation, and operational readiness.
• Drive execution through structured governance, ensuring risks, issues, and decisions are actively managed and escalated as required.
• Coordinate cross-functional activities across Clinical Operations, Clinical Systems, IT, R&D Quality, and external vendors.

• Project manage all activities required to establish sustainable post-go-live operations for Vault Clinical, aligning with the operational support model.
• Ensure readiness across:

• Business processes and SOP/WRK updates
• Training, communications, and adoption activities
• Support model implementation (handover to operational teams)

• Track and drive completion of readiness deliverables, ensuring alignment with governance and inspection readiness expectations.

• Lead the structured decommissioning of client's CTMS, ensuring compliance with GxP and data retention requirements.
• Coordinate:

• Data archival and migration activities
• System shutdown planning and execution
• Documentation and audit trail preservation

• Ensure all decommissioning activities are fully documented, traceable, and aligned to regulatory and internal standards.

• Ensure all project activities comply with GxP best practices, data integrity, and internal procedural requirements, consistent with the governance expectations.
• Maintain RAID logs (risks, assumptions, issues, dependencies) and ensure proactive mitigation planning.
• Support governance forums by preparing clear, concise, and inspection-ready updates.
• Ensure alignment with DAI decision-making frameworks and escalation pathways.

• Coordinate with Business System Owners and operational leads to ensure alignment between technical delivery and business change control processes.
• Track project impacts to studies, users, downstream systems, and data integrity—ensuring these are appropriately assessed and communicated.
• Facilitate decision-making by bringing together required stakeholders and ensuring clarity on scope, impacts, and timelines.

• Act as the central coordination point across project stakeholders, ensuring clear and consistent communication.
• Provide structured updates to leadership, including progress, risks, and key decisions.
• Support alignment between programme delivery and operational teams to enable effective transition to business-as-usual.

• Accountable for delivery of project milestones and timelines.
• Contributes to governance and prioritisation forums by providing data-driven insights on delivery status, risk, and readiness.
• Escalates risks and decisions appropriately in line with client's governance and DAI principles.

• Proven experience (typically 5+ years) in project management.
• Demonstrated experience managing large-scale system deployments, migrations, or decommissioning…