regulatory personnel, and other multidisciplinary stakeholders while contributing to study planning, execution, oversight, and reporting activities. The successful candidate will independently manage and be accountable for operational execution of assigned clinical and translational research studies while serving as the primary day-to-day operational resource throughout the study lifecycle. The individual will be responsible for coordinating stakeholders, managing risks, driving study execution, and ensuring studies are delivered in accordance with quality, timeline, regulatory, and organizational expectations. Responsibilities include: Accountable for operational execution of assigned clinical and translational research studies from start-up through closeout and reporting. Serving as the primary day-to-day operational lead for assigned studies. Collaborating with investigators, sponsors, sites, vendors, biostatisticians, clinical data managers, regulatory personnel, and other stakeholders throughout the research lifecycle. Developing and maintaining study timelines, project plans, risk registers, communication plans, and operational tracking tools. Facilitating study team meetings and ensuring timely completion of deliverables and action items. Essential Functions: Serves as the primary day-to-day operational resource for assigned clinical and translational research studies. Responsible for day-to-day management of assigned clinical studies, including identifying and resolving study related issues, and assigning appropriate study tasks to Clinical Study Assistants and Clinical Study Associates as needed to ensure timely and effective study execution. Independently manages clinical study timelines, milestones, risks, deliverables, and operational activities. Coordinates communication and collaboration among investigators, sponsors, sites, vendors, and internal teams. Identifies operational risks and develops mitigation strategies to support successful study execution. Monitors study performance and proactively address issues affecting timelines, quality, compliance, or operational objectives. Minimum Education and Experience: Bachelor's degree in Clinical Research, Health Sciences, Public Health, Nursing, Biological Sciences, Healthcare Administration, Business Administration, or a related field. Minimum five (5) years of relevant clinical research, project management, study coordination, or research operations experience. One (1) year of Clinical Study Manager experience required. City: New Brunswick State: NJ Posting Number: 26ST1892
