Global Study Associate Director

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About the role

Job Title: Global Study Associate Director Location: Durham, NC Introduction to role: Are you ready to lead global clinical studies that turn cutting-edge science into evidence that changes patients’ lives? In this role, you will own the end-to-end delivery of complex studies, guiding cross-functional teams and external partners from handover to close-out and archiving, so our medicines can reach those who need them faster. You will operate at the center of study execution—aligning strategy with action, translating risk into robust plans, and making data-driven decisions that safeguard quality, timelines, and budget. Working with knowns and unknowns, you will champion clarity, pace, and accountability while shaping how we use digital, data, and technology to advance clinical development. What could you accomplish by uniting diverse experts around a clear plan—and keeping a global study inspection-ready, on budget, and ahead of schedule? Accountabilities: • Study Leadership and Delivery: Lead and empower a cross-functional study team and/or oversee outsourced partners to deliver against agreed timelines, budget, and quality standards; hold accountability for one or several studies and drive milestone achievement. • Cross-Functional and External Communication: Orchestrate clear, timely communication across functions and vendors; plan and lead investigator meetings and key study forums to maintain alignment and momentum. • Study Documentation Ownership: Provide input to and hold accountability for essential study documents from Clinical Study Protocol through Clinical Study Report in line with SOPs and regulatory requirements. • Vendor Strategy and Oversight: Ensure CROs and other vendors (e.g., central labs, IXRS, ePRO) deliver to contract, timeline, and budget; document oversight, escalate issues, and support vendor selection when needed. • Quality and Risk Management: Build and maintain risk-based quality plans, proactive risk and contingency strategies, and clear escalation pathways; champion a culture of issue prevention and rapid resolution. • Data and Systems Integrity: Ensure accuracy and currency of study-level systems (e.g., ACCORD/ABACUS, PharmaCM); use operational data to drive decisions and transparency. • Performance and KPI Management: Monitor operational and quality KPIs, track progress against plans, and communicate risks, mitigations, and impacts to study leadership and the Clinical Program Team. • Issue Management and CAPA: Identify, report, and resolve quality issues; coordinate corrective and preventive actions with stakeholders and communicate outcomes to CPT, QA, and functional leaders. • Trial Master File Excellence: Oversee TMF strategy, plan, and Expected Document List; ensure ongoing QC and continuous inspection readiness. • Compliance and Governance: Secure timely compliance with governance controls (e.g., Delegation of Authority, Sunshine Act, clinical trial transparency) and uphold ICH-GCP, SOPs, policies, and best practices. • Budget Ownership: Re-forecast and manage the study budget throughout the lifecycle; provide clear budget status, risks, and mitigations to the CPT and drive disciplined change control. • Inspection Readiness: Serve as the primary Study Management point-of-contact during audits or inspections; maintain a constant state of readiness with robust documentation and processes. • People Development and Mentoring: Provide ongoing feedback to team members and line managers; mentor less experienced colleagues to build capability across the organization. • Continuous Improvement and SME Contributions: Lead or contribute to non-drug project work, process enhancements, and act as a subject matter expert for Study Management systems or processes. Essential Skills/Experience: •

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