• Oversight of site level tasks associated with efficient site activation in accordance with ICH/GCP guidelines, local regulations, SOPs and project requirements • Identifying potential research sites that align with the study's criteria and assessing their capabilities and resources • Conduct initial site outreach, i.e., site engagement, collection of Confidentiality Agreement, and feasibility survey • Remote Pre-Study Visits and follow up documentation, including visit preparation, trip report completion, and other documentation as required • Support customization and translation of informed consent forms and patient-facing materials • Collect, track and perform a quality review of all essential documents required for effective and compliant study site activation • Maintenance and ongoing awareness of site regulatory compliance, supporting IRB/Independent Ethics Committee (IEC) annual renewals, PI change-over, and document expirations • Actively participate in team meetings to facilitate study progress and implement action plans for site level risks, underperforming sites, or issues impacting project milestones • Support the CRA team in preparing for site initiation visits (SIVs) • Responsible for submissions to and liaise with applicable IRB/IEC, Third Bodies, and Regulatory Authorities • Perform initial contract and budget negotiations with the sites • Ensure high quality documents are filed in applicable systems in accordance with SOPs and project requirements and that the Trial Master File (TMF) is updated and audit ready at all times • Track the progress of the start-up process and ensure that the research site meets all requirements and deadlines • Perform Case Report Form (CRF) review and data validation against source documentation according to protocol and guidelines as applicable in combination with monitoring for site protocol deviations.

• Own escalations end‑to‑end: Lead resolution of complex PAs, denials, step therapy overrides, tier exceptions, continuation‑of‑therapy, and reauthorization timelines to keep treatment on schedule. • Navigate benefits expertly: Determine the correct coverage path across medical vs. pharmacy benefits, formulary status, HCPCS/CPT coding, site‑of‑care, and specialty classification; advise partners on buy‑and‑bill vs. pharmacy fulfillment. • Direct payer/PBM advocacy: Conduct targeted outreach to plans and PBMs to expedite decisions, correct errors, and secure patient access; prepare and submit clinical criteria summaries and appeals packets as needed. • Clinic and provider support: Interface with clinicians and partner staff to identify missing documentation, clarify criteria, and align on next steps; coordinate with pharmacies for shipment, copay confirmation, and consent. • Documentation and systems: Maintain precise status, outcomes, and next steps in EHR/CRM/Airtable; ensure audit‑ready records across all cases. • Quality and mentorship: Coach BPO team members, perform case QA, and contribute to SOPs, checklists, and templates. • Insights and improvement: Track payer behavior and bottlenecks, propose fixes, and partner with leadership on process and tooling improvements.