The Clinical Study Team Lead (CSTL) is the single point of accountability for input into study design to ensure feasibility of execution, planning and delivery of clinical studies on time, within the approved budget and with quality.
The CSTL is a Clinical Development expert focused on the execution of clinical trials and brings that expertise to the design & conduct of clinical studies in alignment with the program and portfolio strategies for the specific category(ies)/Therapeutic Areas
The CSTL is an experienced project manager and matrix leader accountable for leading the study team delivery of multiple complex global studies and/or programs.
The CSTL is responsible for developing clinical trial timelines and overseeing budgets for their clinical studies.
The CSTL will partner and collaborates with functional line leadership to ensure optimal resourcing of the study team
The CSTL is responsible for proactive risk management and inspection readiness for their clinical study(ies).
May lead the delivery of Module 2 and 5 deliverables to support market authorizations
May work at the program level. When working at the program level the CSTL is accountable for developing the execution strategy and managing the timelines, budgets, and quality across multiple studies in the program.
Study Team Leadership
• Leads 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
• Accountable to ensure effective study team scheduling, records and communications in partnership with the CTA
• Accountable for strategic planning and decision making at the study level in line with program objectives
• Accountable for issue resolution
• Utilizes negotiation, facilitation, meeting management, and conflict resolution skills to enhance cross-functional study team performance and accountable for effective study team operations
• Leads study team chartering and team health check process
• Partners and collaborate with functional line leadership to ensure optimal resourcing of the study team
• Represents the study team at appropriate medicine team and sub-team discussions
• Escalates issues to Clin Ops Head when study team has been unable to resolve or adequately manage/mitigate Quality Oversight
• Drives the monitoring and remediation of quality metrics and completion of the remediation tracker • Drives functional lines to ensure inspection readiness
• Ensures maintenance and accuracy of Standard Operating Procedures (SOP) log
• Maintains 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 Study Metrics & Reporting
• Acts as a single, authoritative source of study information and leads study level status reporting per organizational norms and expectations
• Ensures systems are maintained with up to date program status, risks, and issues
• Oversees operational metrics across study and partners with functional lines to manage trends Risk Management
• Leads the study team in the management and communication of risk management plans including risk assessment and mitigation strategies
• Proactively identifies operational issues and leads the team in identifying options to de-risk and capitalize on opportunities
• Ensures study risk planning is ongoing throughout the study
• Leads the study team in proactive problem solving and risk management Governance & Decision Points
• Drives the proactive planning to navigate the team through governance and decision point milestones to support on-time delivery of study deliverable on-time to maintain development timelines
• Leads preparations for and presents the study to relevant governance per organizational norms and expectations
• Ensures Quality Gate timing planning, and team readiness In some instances, may support the following activities: Business Development
• A member of the GPD due diligence team for business development opportunities. Partner with GPD leaders to assess development program timelines and budgets to inform the assessment of opportunities for the category Submissions
• Leads cross functional Module 2/5 submission sub- teams with accountability for delivery and an overall operational strategy
• Develops and leads execution of the data and document delivery plans at key milestones such as POC, DP3 decisions, submissions, and rapid response. Manages other submissions activities as necessary
• Accountable for managing overall submission CD&O sub-team timelines, budgets, and quality targets
• Accountable for building, forecasting, and managing the CD&O submission budget
• Oversees operational metrics across submission sub-teams and manages trends and escalations
• Ensures comprehensive operational input to submission plan
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Training and Education:
• Extensive clinical trial conduct, global clinical trial operations, and a thorough understanding of the processes associated with project and study management, knowledge of Good Clinical Practices (GCPs), monitoring, clinical, and regulatory operations
• Bachelor's degree in one of the disciplines related to drug development or business required. Advanced degree desirable
• Preferred 10 or more years of relevant experience
• Broad experience in a Clinical Trial Execution discipline (e.g. senior study management expertise, lead data management expertise, clinical leadership expertise)
• Demonstrated project management and cross-functional leadership experience
• Experience in understanding of key drivers impacting budgets and experience building a Clinical Trial Budget and managing project to budget Skills:
• Strategic thinking and targeted problem-solving skills • Ability to lead cross-functional teams, identify, resolve & escalate issues
• Project management expertise
• Ability to leverage negotiation and conflict resolution skills to enhance team performance and delivery
• Ability to represent & communicate clearly to senior leaders and governance bodies
• Ability to understand and assimilate high-level data from all functions
• Strong communication and interpersonal skills
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
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