COMET Regional Lead

The Close-Out & Maintenance (COMET) Regional Lead is accountable for the strategic direction, performance, and delivery of clinical trial maintenance and close-out activities across one or more regions within the GSSO organisation. This role leads a multi-layered regional organisation responsible for the timely, compliant, and cost-effective execution of study maintenance and close-out activities, ensuring alignment with regulatory requirements, ICH GCP, and Pfizer standards.

Operating as part of a globally connected leadership team, the Regional Lead works in close partnership with peer Regional Leads to ensure consistent, standardized, and high-quality COMET delivery across all regions, while enabling appropriate regional flexibility. The role plays a critical part in shaping and executing the COMET operating model, driving operational excellence, and ensuring seamless collaboration across Country Operations, Study Management, Site Operations, and enabling functions.
Job Responsibilities
Regional Leadership & Global Alignment

- Lead the strategy and execution of COMET delivery across one or more regions, ensuring alignment with global priorities and performance expectations

- Partner closely with peer Regional Leads to ensure consistency in delivery, processes, and performance standards across regions

- Contribute to the ongoing evolution of the COMET operating model, ensuring scalable and standardized approaches are adopted globally

- Act as a regional subject matter expert, providing insight into regional needs, risks, and opportunities to shape global direction

- Support the development and alignment of global priorities through active participation in COMET leadership forums

Operational Delivery & Performance Management

- Ensure high-quality, timely, and compliant delivery of:
- Ongoing study maintenance activities (e.g. document updates, regulatory tracking, contract/budget amendments)

- Study close-out activities

- TMF finalisation and archival readiness

- Establish and monitor KPIs across assigned regions, including cycle times, quality metrics, and productivity measures

- Drive consistency of delivery through standardized processes, tools, and performance frameworks

- Identify and address risks to delivery, working collaboratively across regions to implement solutions and share best practices

- Ensure strong inspection readiness and support audit activities across the region

Resource & Vendor Management

- Lead a regional organisation (typically multiple teams) including managers, individual contributors, and contingent/vendor resources

- Oversee resource allocation, capacity planning, and demand forecasting for assigned regions

- Partner with peer Regional Leads to optimize resource utilisation across regions, balancing workload and capability

- Support the implementation and oversight of vendor/FSP models, ensuring effective and compliant external partnerships

- Contribute to financial planning and cost optimization initiatives within the regional scope

Process Excellence & Compliance

- Drive standardisation and harmonisation of maintenance and close-out processes across regions in partnership with other Regional Leads

- Ensure full compliance with ICH GCP, regulatory requirements, and Pfizer SOPs and policies

- Partner with Process & Standards teams to implement improvements, training, and governance frameworks

- Promote a culture of continuous improvement, identifying opportunities to enhance efficiency, quality, and scalability

- Ensure consistent application of systems, tools, and documentation standards to maintain data integrity and audit readiness

Stakeholder Engagement & Collaboration

- Build strong partnerships with:
- Study Management & Clinical Study Teams

- Site Operations and Country Operations

- Regulatory, Quality, and enabling functions

- Act as a key point of contact for regional stakeholders while ensuring alignment with global COMET leadership

- Collaborate