• 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