Senior Project Manager – Vault Clinical DR Validation
Fosters City CA – Onsite - Full TIme
Experience Range: 10-20 years
Ideal candidate will have domain from Life Sciences, Pharmaceutical, Biotechnology, or Healthcare ( Not Healthcare Insurance)
Primary skills
- 10+ years of Project Management experience,
- Experience in Disaster Recovery / DR project planning and coordination
- Experience managing complex technical projects involving Project planning, scheduling, and milestone tracking
- Risk, issue, and dependency management (RAID).
- Strong understanding of project management methodologies (Agile, Scrum, Waterfall, Hybrid).
- Experience working within Life Sciences, Pharmaceutical, Biotechnology, or Healthcare organizations.
- Knowledge of GxP regulations, validation processes, and regulated environments.
- Experience managing stakeholders across business and technical organizations.
- Strong risk management, communication, and leadership skills.
- Proficiency with project management tools such as Jira, Azure DevOps, Smartsheet, MS Project, or similar.
- Manage communication across business, IT, vendors, and leadership teams.
Role Summary -
We are seeking an experienced Project Manager - Responsible for planning, coordinating, tracking, and providing end-to-end project management support for the Vault Clinical Disaster Recovery (DR) Validation project, ensuring DR testing activities are completed according to the agreed scope, timeline, dependencies, and milestones. The role will work closely with Clinical/Vault teams, technical teams, validation stakeholders, and project leadership to manage progress, risks, issues, dependencies, and stakeholder communications
Why This Role Matters -
This position is critical for customer who can able to independently handled all PM experience at Onsite
What You'll Do/
Job Description of Role*
- Develop and maintain the DR Validation project plan, including activities, dependencies, milestones, deliverables, and target dates.
- Coordinate DR validation activities across business, application, infrastructure, validation, and other applicable teams.
- Track project progress, action items, milestones, and deliverables through completion.
- Facilitate regular project status meetings, working sessions, and stakeholder updates.
- Maintain RAID logs covering risks, assumptions, issues, dependencies, and mitigation actions.
- Identify schedule risks, cross-team dependencies, and potential blockers and drive them toward resolution.
- Coordinate DR testing readiness, execution, follow-up activities, and completion tracking.
- Ensure project documentation, status reports, meeting minutes, and action trackers are maintained.
- Provide regular project status reporting to project leadership and stakeholders.
- Support stakeholder communication and escalation management as required.
- Provide project management support through completion of the agreed Vault Clinical DR validation and testing activities.
Soft skills/other skills -
Communication Skills:
Communicate effectively with internal and customer stakeholders
Communication approach: verbal, emails and instant messages
Interpersonal Skills:
- Strong interpersonal skills to build and maintain productive relationships with team members
- Provide constructive feedback during code reviews and be open to receiving feedback on your own code.
Problem-Solving and Analytical Thinking:
- Capability to troubleshoot and resolve issues efficiently.
- Analytical mindset
Task/ Work Updates
- Prior experience in working on Agile/Scrum projects with exposure to tools like Jira/Azure DevOps
- Provides regular updates, proactive and due diligent to carry out responsibilities
What Success Looks Like (6–12 Months) -
Expected Outcome
Within the first 6–12 months, the Technical Project Manager will have successfully established and driven the Data Strategy program, delivering measurable business and technical outcomes, including:
Strategic Program Delivery
- Successfully execute key milestones of the Data Strategy roadmap on schedule and within budget.
- Establish a structured governance model, including steering committees, stakeholder forums, and project reporting mechanisms.
- Align business objectives with data initiatives and ensure stakeholder buy-in across functions.
Data Governance & Compliance
- Implement or strengthen data governance processes, standards, and controls.
- Ensure data-related initiatives comply with GxP requirements and organizational regulatory standards.
- Facilitate risk assessments and remediation plans for data quality, compliance, and operational risks.
- Stakeholder Engagement
- Build strong relationships with business leaders, IT teams, data owners, and external partners.
- Establish clear communication channels and executive-level reporting that provide visibility into project health, risks, and achievements.
- Drive consensus and decision-making across cross-functional teams.
Secondary Skills (Good to have)
- Veeva Vault / Vault Clinical knowledge
- Clinical Trial / Clinical Operations domain knowledge
- Disaster Recovery and Business Continuity concepts
- GxP / CSV / Computer System Validation awareness
- Quality and compliance processes
- Agile / Waterfall project methodologies
- Jira, Azure DevOps, Smartsheet, MS Project, or similar project-management tools
- Microsoft Excel / PowerPoint / Teams / SharePoint
- Experience with enterprise application validation/testing
- Vendor and third-party coordination
Why Join Us -To be part of one of the most important engagements for our customer, supporting Business Process Owners and Project Managers to define, document, and deliver complex business and system requirements for the Data Strategy projects,
- Leads requirements refinement, including current/future state analysis, requirements documentation, prioritization, and stakeholder alignment.
- Refine existing user and functional requirements specification.
- Owns User Acceptance Testing planning and execution.
- Partners with the Validation team to ensure testability of requirements and release readiness.
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