Project Manager, Clinical Trial Capabilities, NextGen Clinical Systems support

Project Manager, Clinical Trial Capabilities, NextGen 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 GILDA CTMS platform.

The role will ensure coordinated execution across business, IT, Quality, and Clinical Operations, driving delivery in line with governance, compliance, and operational sustainability requirements.
The Project Manager will work closely with the Program Lead, Business System Owners, and cross-functional stakeholders to ensure timely, controlled, and inspection-ready transition from GILDA to Vault Clinical as well as additional projects/workstreams as needed.

Key Responsibilities

Project Leadership & Delivery

• Lead end-to-end planning and execution of Vault Clinical operational setup and GILDA 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.

Vault Clinical Operational Readiness

• 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.

GILDA Decommissioning

• Lead the structured decommissioning of GILDA, 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.

Governance, Risk & Compliance

• 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.

Change Control & Cross-Functional Alignment

• 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.

Stakeholder Engagement & Communication

• 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.

Decision Making & Accountability (DAI Aligned)

• 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.

Required Qualifications & Experience

• Proven experience (typically 5+ years) in project management.
• Demonstrated experience managing large-scale system deployments, migrations, or decommissioning activities.
• Good understanding of clinical trial operations, system validation, and regulatory expectations.
• Experience working within matrixed, cross-functional environments.

Key Competencies

• Strong project planning and execution discipline (timelines, dependencies, risk management)
• Clear understanding of system governance vs project delivery responsibilities
• Ability to translate complex programmes into executable plans
• Excellent stakeholder management and communication skills
• High attention to detail with focus on inspection readiness and compliance

The salary range provided for this contract role represents our good faith estimate for this position. Within the range, individual offers will vary based on the selected candidate's experience, industry knowledge, technical and communication skills, location and other factors that may prove relevant during the interview process (W2 or C2C). In addition to compensation, the company provides eligible W2 employees with a comprehensive and highly competitive benefits package.

I.T. Solutions, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.