• Establish and maintain strong professional and collaborative relationships with investigator sites • Track key performance metrics to assess site performance • Serve as an internal resource to champion patient perspective and voice across product development continuum • Identify investigator sites, PAGs and communities in alignment with portfolio strategy • Provide support to study teams and Clinical Research Organizations (CROs) to ensure timely delivery of clinical trials

• Responsible for the management of Clinical Trials from vendor selection through Clinical Study Report (CSR) completion. • Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements. • Create and implement study-specific clinical monitoring tools and documents, including informed consent development and EU CTR. • Lead the identification, evaluation, selection, and oversight of clinical trial sites. • Author and implement operational plans to ensure efficient study enrollment and high-quality monitoring activities at clinical sites. • Review/approve vendor and site invoices and track study budget to forecast, working closely with finance and clinical business operations. • Responsible for implementation and oversight of Trial Master File for inspection readiness. • Drive overall process and provide support to cross-functional teams in the development of study documents including study protocols, consent forms and budget templates. • Serve as lead in the creation of project plans, logs, templates, newsletters, and other documents. • Review and approve site specific documents (such as informed consent forms, site budgets, monitoring reports) along with other relevant project team members. • Provide study updates and reports, inclusive of study risks and issues. • Lead internal and external meetings for assigned clinical trial(s), including Investigator Meetings, conferences, events and study management meetings. • Responsible for ongoing study data reviews and data cleaning activities. • Provide oversight of CTA and CRA activities such as site identification, qualification, selection, initiation, data quality, sample tracking, interim monitoring and close out activities. • Manage trial-level quality risk management. • Oversee study supplies management. • Support the development and complete the delivery of study training to investigators, site staff and internal staff on study processes. • Participate in the preparation and follow up of internal process audits, vendor, and study site quality audits as well as regulatory inspections. • Other duties as assigned.

• Design and analyse clinical trials • Drive clinical operations performance, ensuring quality • Oversee the planning, execution, and management of clinical trials • Provide strategic direction and guidance to cross-functional teams • Collaborate with key stakeholders to develop and implement innovative clinical trial strategies • Ensure compliance with regulatory requirements and industry standards

• Provide operational oversight and support for multiple clinical research sites within the network. • Monitor site performance metrics including enrollment, retention, protocol compliance, data quality, query resolution, and study timelines. • Ensure consistent implementation of SOPs, operational workflows, and best practices across all assigned sites. • Identify operational gaps and implement process improvement initiatives to enhance efficiency and site performance. • Support study startup activities including feasibility, site activation, staffing readiness, staff training, and sponsor/CRO coordination. • Partner with site leadership to optimize resource allocation, staffing coverage, and workflow management. • Ensure adherence to GCP, FDA regulations, ICH guidelines, HIPAA, and sponsor protocols. • Support audit readiness and assist with sponsor, CRO, and regulatory inspections/audits. • Monitor protocol deviations, CAPAs, and quality-related issues and collaborate with site teams on corrective actions. • Promote a culture of compliance, quality, and patient safety throughout the site network. • Serve as a primary operational partner to PIs, Sub-Is, CRCs, and site staff. • Provide mentorship, coaching, and operational guidance to clinical research personnel. • Assist with onboarding, training, and ongoing development of site staff. • Foster strong collaboration and communication across cross-functional teams and site locations. • Track and report on key operational and financial metrics across assigned sites. • Support achievement of enrollment targets, study milestones, and organizational growth initiatives. • Collaborate with leadership on strategic initiatives, expansion opportunities, and operational scaling efforts.