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The Senior Clinical Study Lead is responsible for the global execution of complex clinical trials, ensuring compliance, managing study timelines and budgets, overseeing vendor engagements, and leading the clinical study teams.

Lead global execution of large/complex hematology clinical trials from design through close-out. Accountable for timelines, budget, regulatory compliance, CRO/vendor management, site selection and monitoring, data quality, supplies forecasting, audit/inspection readiness, team and line management, and process improvements.

Lead planning, coordination, and delivery of commercial meetings, congresses, and trainings across multiple geographies. Manage vendors, budgets, contracts, compliance, attendee operations, SOPs, KPIs, and event platforms while partnering with cross-functional and alliance teams to ensure measurable impact and field readiness.

This role involves driving market access strategies for rare disease treatments in the EU, engaging with healthcare policymakers, and collaborating with cross-functional teams to ensure access.

The Senior Manager leads regulatory submission compliance, ensuring documentation aligns with global requirements, managing CMC processes, and coordinating cross-functional activities to support clinical trial releases.

The Director Program Operations Leader manages clinical operations, overseeing quality, budgets, and timelines for oncology clinical trials, while ensuring compliance with regulations and SOPs.

Coordinate and support CMC regulatory submissions for CTAs, ensuring compliance with global health authority requirements and facilitating communication among stakeholders.

The Associate Director in CMC Regulatory Affairs leads global regulatory strategies for combination products and medical devices, mentors staff, and interacts with global regulatory authorities.

Responsible for managing and executing procurement activities in global clinical CRO category, negotiating supplier contracts, and ensuring compliance with regulations.

The Program Operations Leader oversees complex clinical programs, ensuring quality, timelines, and budgets are met. They manage clinical operations, staff development, and vendor relationships, providing operational insights and driving strategic planning within clinical trial management.