Cross-Functional Team Leadership: Lead and coordinate cross-functional project teams (clinical operations, data management, biostats, safety, regulatory, medical writing). Facilitate cross-functional team meetings, ensure documentation of decisions and action items. Act as Project Manager/Director to direct reports. Serve as the primary institute contact for internal and external stakeholders, and compile necessary data from ORED and IHPC research teams to provide regular project updates to stakeholders (40%).
Clinical Trial Planning & Execution: Lead planning, initiation, and execution of clinical trials from study start-up through closeout. Develop detailed project timelines, milestones, and resource allocation plans. Oversee site feasibility, selection, initiation, monitoring, and closeout. Work with clinical monitors, sponsors, and study teams to ensure high-quality site engagement and performance (25%).
Compliance, Risk, and Quality Oversight: Ensure compliance with ICH-GCP, FDA/EMA regulations, and internal SOPs. Proactively identify risks and develop/implement mitigation strategies, and lead issue resolution efforts to minimize study disruption and escalation. Support audit and inspection readiness activities (20%).
Resource Oversight: Development of clinical trial budgets for funding submissions and ensure adherence to project scope, budget, and deliverables. Oversee the selection, management, and performance of equipment and supply acquisition, maintenance, CROs and other vendors (e.g., labs, imaging providers, study specific vendors), equpment. Review and approve third party invoices and ensure adherence to contractual terms. Interface with the finance office in the Office of Research to ensure that allocation of resources to research projects are within the institute scope of funding (10%).
Other duties as assigned (5%).