Director

• Lead and coordinate a cross-functional study team (core and extended) in accordance with SOLID and RACI to ensure study progress and milestone achievement
• Serve as main liaison between study team and Clinical Program Team (CPT) from handover to close-out and archiving
• Provide direction, guidance and facilitate communication across functions according to study-specific communication plan
• For outsourced studies, act as primary sponsor contact for CRO Project Manager and maintain/document CRO oversight
• Provide input into and hold accountability for development of essential study-level documents from CSP through CSR
• Ensure external service providers perform to contracted goals and maintain oversight documentation
• Develop and maintain study plans (e.g. global study management plan, SPP) including quality and risk management planning
• Oversee study performance against plans, milestones and KPIs using company tracking systems (SPP, CTMS, eTMF dashboards)
• Identify and report quality issues and collaborate on corrective action plans (CAPAs)
• Oversee TMF completion and ensure QC activities for TMF completeness
• Manage study budget re-forecasting and provide budget progress reports to CPT, including financial risks and mitigations
• Ensure studies are inspection-ready and act as primary LDO Clinical Operations contact for audits/inspections
• Provide feedback for team members' performance and mentor less experienced colleagues
• Participate in process improvements and/or lead improvement projects as agreed with manager

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