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Clinical Study Team Lead
4 months ago
JOB SUMMARY.
- Clinical Development expert focused on the execution of clinical studies 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.
- 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.
- Experienced project manager and matrix leader accountable for leading the study team delivery of multiple complex global studies and/or programs.
- Responsible for developing and overseeing clinical study timelines and budgets. - Partners and collaborates with functional line leadership to ensure optimal resourcing of the study team.
- Responsible for proactive risk management and inspection readiness for their clinical study(ies). Your responsibilities may also include:
- Ensures comprehensive operational input to submission plan.
- Lead 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.
- 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.
- Work at the program level; 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.
- DESCRIPTION:
- Provides quality oversight to the Clinical Research Organization (CRO) and of the CRO deliverables related to study execution.
- Leads and coordinates the execution of a 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.
- Provides input to and supports compilation of sections to Clinical Study Reports and provide program-level insights. Provides leadership to the teams in the setting of realistic recruitment targets and delivery milestones.
- Monitors CRO and vendor contracts for out-of-scope activities and budget spend/invoices for assigned vendors.
- Provides centralized Pfizer Oversight to fully outsourced studies.
- 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. JOB
- RESPONSIBILITIES
- 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 CSTA.
- 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 and team health.
- 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.
- 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 opportuniti
