PMO Governance & Program Leadership
- Establish, implement, and oversee PMO governance frameworks, processes, and standards across multiple clinical trial programs.
- Define and manage program plans, schedules, dependencies, risks, and mitigation strategies.
- Ensure alignment of program execution with organizational objectives, regulatory standards, and best practices.
End-to-End Program Delivery
- Lead planning, execution, monitoring, and successful delivery of complex clinical trial programs.
- Drive quality, compliance, and operational excellence throughout all phases of program lifecycle.
- Monitor budget, resource allocation, program health, KPIs, and deliver timely status reporting to senior leadership.
Stakeholder & Cross-Functional Management
- Serve as a single point of accountability for program governance and stakeholder engagement.
- Collaborate closely with Business, Clinical Operations, Development, Testing, Validation, and Operations teams to ensure seamless execution.
- Facilitate cross-functional communication, issue resolution, and decision-making across global and regional teams.
Risk, Compliance & Quality Oversight
- Proactively identify risks, issues, and bottlenecks; drive structured mitigation and escalation processes.
- Ensure documentation and program artifacts are compliant with regulatory guidelines (GCP, FDA, EMA, etc.).
- Maintain audit readiness and support internal/external inspections.
Leadership & Strategic Support
- Mentor and guide PMO team members and project managers.
- Contribute to continuous improvement initiatives, PMO maturity development, and best-practice adoption.
- Provide strategic insights to leadership based on program performance, trends, and lessons learned.