CARE

• The Director, Clinical Delivery Strategy is a senior strategic and operational leader embedded within the Clinical Delivery organization. • This role is responsible for driving scalable, durable improvements across Clinical Delivery teams. • This role sits at the intersection of strategy, operations, and execution, translating enterprise priorities into practical improvements. • The Director is responsible for identifying high‑impact opportunities, designing improved operating models and workflows, and leading complex change initiatives. • Success in this role requires deep partnership within Clinical Delivery leaders, frontline teams, Data & Analytics, Product/Technology, and senior leadership.

• Support the development and execution of engagement and retention of our patients through health screenings and studies • Optimize the patient journey to improve engagement rates • Activate and optimize marketing strategies that span the entire customer journey • Implement retention campaigns to improve engagement with study participants • Work with development and analytics teams to further build out marketing automation

• Lead the development and execution of digital campaigns aimed at increasing patient engagement and recruitment. • Develop and implement digital marketing strategies to support patient recruitment. • Manage paid advertising campaigns across search, social, and display platforms. • Analyze performance data to uncover actionable insights and drive channel optimizations. • Manage and allocate a multi-million-dollar digital marketing budget to maximize overall performance. • Work with development and analytics teams to further build out our marketing automation.

• The CTMS Operations Manager owns CTMS platform governance, technical support for other Care Access users, operational reporting, and the CTMS operations team that executes these requirements. • This role is both people leader and technical owner: final gatekeeper for CTMS site and study builds, owner of platform/configuration standards and release/change control, primary liaison to our CTMS vendor(s), SSU, Source, Study Ops, and QA, and lead for CTMS-sourced operational reporting. • The role ensures build quality, SOP/GxP compliance, audit readiness, and continuous improvement of CTMS processes and KPIs.

• Drives and Manages studies or projects according to scope of work, timelines, and quality standards. • Supports building a strategy to deliver the trial or project as per protocol and timelines. • Monitors and analyses project status to ensure successful completion of project parameters, milestones, timetables. • Understands proactively manages risks on trials or projects and implements mitigations whilst working in a cross functional team. • Acts as principal liaison between Sponsor and Care Access by facilitating the flow of information between Care Access and client. • Appropriately escalates any issues or potential issues as per escalation pathways; and provides timely project updates to upline management and/or Senior Leadership at Care Access. • Coordinates a cross functional team to support delivery of the clinical trial. • Holds teams accountable for delivery and success of the trial. • Leads teams to successfully deliver in their areas. • Coordinates activities of all functional departments and vendors involved in the project. • Works with team and management to develop plans/guidelines for project implementation using Care Access tools. • Identifies data and analytics required to allows data-driven decisions and continuously monitors ongoing project performance. • Evaluates growth opportunities of current engagement or potential engagements; helps develops the strategy for various initiatives. • Ensures teams are entering and updating internal tracking tools. • Works with team to identify potential risks, develop contingency plans. • Provides Sponsor with timely project updates, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work • May discuss and obtain feedback from Sponsors regarding Care Access’s performance to date. • Plans and communicates to team members to study specific tasks and priorities for projects. • Delegates, as appropriate, assigned responsibilities to project team members. • Liaises with managers in all functional areas within Care Access to optimize performance and utilization of the project team members. • Ensures that appropriate assessment and coordination of project/protocol specific and therapeutic area training needs and activities are occurring for the team members as needed. • Schedules, leads, and follows up on pre-identified meetings. Documents, sends meeting minutes and follows-up on action items. May be internal and/or external. • Maintains project logs and trackers. • Provides recommendations and alternative resolutions to project-specific challenges through established escalation channels. • Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate. • Escalates identified findings from periodic quality reviews and peer feedback reports. • Collaborates with fellow CTMs and department leadership on best practices.

• Manage Inbound Calls – Handle a high volume of incoming and outgoing calls with professionalism and efficiency, ensuring that all participant inquiries are addressed promptly. • Provide Participant Support: Assist participants by answering questions, providing information, and resolving concerns related to clinical trials and other services offered by Care Access. • Routing Calls: Efficiently route calls to the appropriate departments • Documentation: Accurately document all call interactions in our CRM system and ticketing system to ensure seamless communication and follow-up. • Collaboration: Work closely with other team members and departments to ensure a unified and efficient approach to participant experience.

• Oversee vendor engagement during clinical trial start-up and execution. • Ensure vendors are qualified, contracted, and aligned with study protocols and activation timelines. • Provide clinical insight to the Vendor Management and SSU teams to support vendor selection, feasibility, and site alignment. • Monitor vendor performance, proactively raise risks based on historical knowledge, and escalate concerns impacting KPIs. • Review, negotiate, and manage contracts throughout their lifecycle, including renewals and amendments.

• Support with the annual merit, promotion, and bonus planning process • Utilize market data and internal pay comparisons to provide compensation recommendations for new positions, internal moves, and market reviews • Complete market benchmarking of jobs and participate in salary surveys • Partner with business leaders on the management and administration of short-term incentive plans • Support the business with job description creation and maintenance ensuring compliance with local regulations and FLSA standards • Act as advisor to external partners supporting compensation initiatives • Provide general reporting and data analytics support to HR cross functional teams including HR Operations and Talent • Other job duties as assigned

• Internal Auditing: independently lead and conduct internal audits and related GxP activities including Investigator site audits, process audits, vendor qualifications, vendor audits, and other specialized audits or quality investigations as defined by leadership. • External audits: provide quality and compliance support on sponsor audits, client audits, and regulatory inspections. • Quality Issue/CAPA management: support RCA/CAPA development, tracking, and completion. Works with department to implement and verify CAPAs. Evaluate audit findings, review Quality Issue classification, and review documentation related to QI management. Perform effectiveness checks. • Documentation and reporting: Produce clear and evidence-based quality systems documentation. Display report writing capabilities and an ability to work within timelines. Be organized and capable of demonstration of ALCOAC. Review informed consent forms, investigator site files, and source documents for accuracy. • Inspection readiness: promote a culture of inspections readiness and continuous improvement. Be flexible to work with risk-based audit agendas and shifting priorities. • Regulatory compliance: be knowledgeable of evolving GxP guidelines. Ability to critically think, eagerness to learn, and commitment to ensuring compliance. Knowledge of and able to interpret regulatory guidances such as 21 CFR Part 11/ Part 312, ICH GCP E6 (R3). • Create and deliver training on Quality and Continuous Improvement activities. • Support completion of RFP/RFI (Request for proposals/information). • Learn and engage with digital technologies, including artificial intelligence. • Support drafting for or conduct quality reviews of SOPs and provide support of SOP management. • Provide AI project quality support, QC and consultation. • Support other activities related to the management of QMS and accuracy of data. • Support GxP and non GxP quality issues and/or projects needing quality consultation and support

• Populate CTMS entries (visits, procedures, schedules, financial elements, site personnel) according to company requirement; prepare and hand off builds to the CTMS Operations Manager for final review/acceptance. • Execute build QC checklists, validate configuration and data, log defects with reproducible steps, remediate where possible, and escalate gating defects to the Manager or vendor. Track first-pass acceptance and defect remediation metrics. • Provide day-to-day CTMS technical support for Study Start-Up (SSU), Source, Study Ops, Site Network and other Care Access users (access requests, role/tag maintenance, runbook guidance); deliver study-specific CTMS training as assigned. • Produce standard CTMS reports and operational dashboards used by SSU/Study Ops; perform ad-hoc data pulls to support study readiness and cross-functional decision-making • Maintain build checklists, runbooks, and training materials; propose process improvements that reduce rework and improve build quality and throughput. • Maintain accurate build documentation and audit trails for study readiness and compliance. • Support the CTMS Operations Manager in vendor ticketing and incident tracking when escalated. • Assist with onboarding and training of new CTMS Analysts and temporary staff.