• Increase the number of new patients filling at Shields partner pharmacies • Lead, coach, and develop a high-performing outreach team • Build scalable processes to launch and optimize patient outreach programs across new health systems • Develop new strategies for sourcing and onboarding patients (e.g., waterfall expansion, direct campaigns, MSOT opportunities, QA, clinic launches) • Monitor performance metrics and support supervisors in achieving enrollment, engagement, productivity, and QA goals • Collaborate with regional teams, in-clinic resources, TRX, and analytics to refine workflows, reporting, and operational capabilities • Use creative approaches (A/B testing, messaging optimization, value storytelling) to enhance patient engagement • Ensure compliance standards are maintained across all outreach activities • Foster a positive, collaborative, high‑energy team culture

• May lead or support a study or studies, depending on size/complexity. • Operational point of contact for trial execution and all trial deliverables • Manages all HQ Operational Activities, including: • Establishes, leads and manages Clinical Trial Team (CTT) • Supports clinical (drug/vaccine) supplies planning • Manages deployment and interactions with external vendors (e.g., IVRS, PRO) • Initiates planning for Investigator meeting and protocol training. • Plans and assesses protocol ancillary supplies • Completes trial set-up and maintains CTMS • Schedules, prepares for, and leads the Recruitment Planning Meeting for the CTT • Initiates recruitment/retention planning & enrollment tracking • Responsible for tracking study related details (e.g., specimens, queries) • Oversees protocol training activities including IMs and CRAs training meetings • Ensures appropriate postings to investigative site portals • Responsible for operational deliverables in preparation for site ready, country allocation and achievement of recruitment targets (with input from others) • Point of escalation for study related operational issues • Responsible for operational details at Operational Reviews • Responsible for creating and maintaining project schedule and collaborating with Program Lead • Sets up and maintains Trial Master File (eTMF) • Ensures alignment of budget with protocol needs • Responsible for executing protocol within the budget • Responsible for creating and maintaining ADI logs • Develops Site Monitoring Plan (SMP) with input from the monitoring excellence group • Develops study related manuals (e.g., administrative binder, lab manuals) • Manages Emergency Unblinding (EUB) Call Center activities • Co-authors newsletters with CS • Approves contracts, invoice payments and change orders for vendors, as necessary • Responsible for end of study reconciliation (clinical & ancillary supplies) • Oversees all HQ close-out tasks • Responsible for ongoing monitoring of trial activities, e.g. dashboards, tracking • Supports CS activities as needed to achieve CTT deliverables • Interface with External Data Coordination and Data Management • Responsible for quality control and inspection readiness at all times • Responsible for risk assessment, mitigation planning and execution

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality. • Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with Procedural Documents, ICH-GCP and local regulations. • Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality. • Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks. • Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. • Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations. • Ensures preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in AZ clinical studies financial system by regular checks of the system and financial reports (as agreed with Director, SMM/ Director, Country Head. • Ensures timely preparation of local Master CSA (including site budget) and amendments as needed. • Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations. • Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol, and in line with SOPs. • Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction). • Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations. • Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans. • Reviews monitoring visit reports (as required and following SOPs) and pro-actively advices the monitor(s) on study related matters. • Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs. • Proactively identifies risks and facilitates resolution of complex study problems and issues. • Organizes regular Local Study Team meetings on an agenda driven basis. • Actively works towards achieving good personal relationships with all Local Study Team members, sites’ staff and global stakeholders. • Reports study progress/update to the Global Study Associate Director/ Global Study Team including SMM Lead. • Contributes to patient recruitment strategy including regular communication with participating Investigators as necessary. • Develops, maintains and reviews risk management plan on country study level: proactively manages sites, stakeholders, local and global vendors and customers to ensure risks are timely identified, mitigated and managed. • Communicates and co-ordinates regularly with National Co-ordinating Investigator / National Lead Investigator on recruitment and other study matters, if applicable. • Plans and leads National Investigator meetings, in line with local codes, as required. • Assists in forecasting study timelines, resources, recruitment, budget, study materials and drug supplies. • Ensures relevant systems required to facilitate business critical, license to operate activities (for example, Safety Reporting, Regulatory submissions, Clinical Trial Transparency) are set-up, updated and access is organised at country level. • Ensures accurate payments related to the study are performed according to local regulations and agreements. • Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP and Procedural Documents. • Ensures completeness of the eTMF and ensures essential documents are uploaded in a timeline manner to maintain the eTMF “Inspection Ready”. • Ensures that all study documents are ready for final archiving and completion of local part of the eTMF. • Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA. • Provides input to process development and improvement. • Provides regular information to Line Managers at country level on study/ies and planned study milestones/key issues. • Updates Line Managers about the performance of the CRAs/CSAs. • Ensures that study activities at country level comply with local policies and code of ethics. • Provides feedback on any research related information including sites/investigators/competing studies that might be useful for the local market. • Ensures compliance with company Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment). • Collaborates with local Medical Affairs team.

• Timely coordination of quality healthcare services for individuals' health needs • Collaborative assessment, planning and advocacy for healthcare options • Client-centered care focused on resource stewardship for both client and healthcare system