• Leads the cross-functional Trial Team (CTT); tracking of project deliverables & timelines. Proactively manages that trial deliverables and milestones are met. Identifies risks and ensures mitigation and contingencies are being initiated and followed through (including management of CAPAs) • Accountable for the delivery of the trial within agreed/projected life of trial budget. Ensures accurate trial budget management, updates for scope changes and reconciliation of trial costs. Is responsible for trial-level contract management, including review & approval of external service provider contracts, change orders and ensures services are delivered per contract • Provides trial level leadership to drive the implementation of feasibility and site selection according to timelines in alignment with and communication to Clinical Operations Leadership (Senior Director/Executive Director) • Provides oversight of all external service providers used for the trial for both in-house and outsourced studies; responsible to ensure selection, and set up, including scope of work (SOW) and specifications are in line with protocol requirements, budget, and timelines. • Work collaboratively with the cross-functional team to ensure the trial is operationalized in compliance with global health authority regulations and guidelines • Partner with Clinical Development, Medical Affairs, Regulatory Affairs, Commercial, Asset Strategy Lead and Program Leadership to ensure EAP and Phase 4 activities are fully integrated into the overall asset strategy and Target Product Profile (TPP) • Provide Clinical Operations leadership to ensure EAPs are compliant, scalable, ethically sound and aligned with regulatory guidance • Work closely with the Executive Director, Expanded Access and Phase 4 Clinical Strategy to ensure the execution of Phase 4 trials address regulatory commitments, payer needs and scientific gaps • Participates in preparation for, and conduct of, Health Authority inspections and internal QA audits. Ensure that the Trial Team operates in a constant state of inspection-readiness. Collaborate with Quality liaisons to ensure quality oversight of assigned trial utilizing the available tools • Ensures Trial Team members have received the appropriate trial-specific training needed for their function; in collaboration with the Study Clinician and Clinical Scientist, the ADCO ensures appropriate trial-specific training is given to Trial Team members and/or to the CRO. Oversee the Clinical Trial Assistant (CTA) in the set-up and coordination of Investigator Meetings, if applicable • Responsible for ensuring transparent status reporting information to relevant key stakeholders • Ensure trial related issues (quality, timelines, budget, resources) are resolved within the function and/or within the CTT and if they cannot be resolved within the function and/or CTT they are escalated to the Senior Director/Executive Director of Clinical Operations in a timely manner • Manages timely and accurate documentation of issue escalation and provides trial-level insight to drive lessons learned and process improvement initiatives during and after trial milestone completion