Job Information Role Summary CSTL is accountable for planning and executing clinical studies, ensuring timely delivery within budget and quality standards, and leading multiple complex global studies or programs. The role involves collaboration with functional leadership for resource optimization and proactive risk management. A clinical operations and development specialist with extensive experience in planning and executing clinical studies, consistently applying this expertise to the design and conduct of trials in accordance with program and portfolio strategies for specific categories or therapeutic areas. Act as a strategic partner providing insights from a clinical operations perspective with functional lines and key stakeholders Serves as the primary contact responsible for providing input into study design, ensuring practical feasibility, streamlined planning, and timely delivery of clinical studies within approved budgets and quality standards. A skilled project manager and matrix leader, accountable for guiding multidisciplinary study teams in the successful execution of multiple complex global studies and programs. Job Responsibilities Lead the study team and associated deliverables across all functions; accountable for managing and driving overall study timelines, budgets, and quality targets to meet or exceed business needs. Lead and coordinate the execution of clinical studies from sourcing strategy and study specification development for requests for proposals, study start-up through database release and inspection readiness to ensure timely delivery of quality study data. Provide input to and supports compilation of sections of the clinical study reports (CRSs). Accountable to ensure effective study team meeting scheduling, records, and communications. Accountable for strategic planning and decision making at the study level in line with program objectives. Accountable for issue resolution and act as point of awareness for clinical trial execution issues. Utilize negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross- functional study team performance and accountable for effective study team operations. Lead study team chartering and team health check process. Partner and collaborate with functional line leadership to ensure optimal study team resourcing. May represent the study team at appropriate asset team and sub-team discussions Escalate issues to Clinical Operations Leadership when study team has been unable to resolve or adequately manage/mitigate. Quality and Risk Oversight Drive monitoring and remediation of quality metrics. Drive functional lines to ensure inspection readiness. Maintain active awareness and appropriate escalation of all Significant Quality Events (SQEs) reported for study and ensures appropriate prioritization and management of events through to resolution. Lead the study team in the management and communication of risk management plans including risk assessment and mitigation strategies. Proactively identify operational issues and lead the team in identifying options to de-risk and capitalize on opportunities. Maintain continuous study risk planning and guide the team in proactive issue resolution and risk management. Vendor Oversight Quality oversight of the Clinical Research Organization (CRO) if required by the Pfizer operating model and of the CRO deliverables related to study execution. Partner with relevant team functions to ensure vendor delivery meets quality and operational plan expectations Study Metrics develop and implement formal operational risk management plans across the asset/program. Ensure comprehensive operational input to submission plan. Leads the delivery of Module 2/5 deliverables to support market authorizations including leading cross functional Module 2/5 submission sub- teams with accountability for overall operational strategy. Manage other submissions activities as necessary. Accountable for managing overall submission CD
Clinical Study Team Lead in Kent employer: Pfizer
At Pfizer, we pride ourselves on being an exceptional employer, offering a dynamic and inclusive work culture that prioritises employee well-being and professional growth. Our hybrid work model fosters flexibility, allowing you to balance your personal and professional life while contributing to groundbreaking advancements in healthcare. With a commitment to diversity and a focus on empowering our employees, you'll find meaningful opportunities to make a real impact in the lives of patients around the world.
