biostatisticians, clinical data managers, 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. Essential Duties and Responsibilities include the following: Serves as the primary day-to-day operational resource for assigned clinical and translational research studies. Independently manages 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. Facilitates study team meetings and drives accountability for assigned action items and deliverables. Ensures study activities comply with applicable regulatory requirements, organizational standards, and best practices. Supports study reporting, closeout, and lessons learned activities. Contributes to onboarding, mentoring, knowledge sharing, and continuous improvement initiatives. Ensures eTMF completeness, quality, and inspection/audit readiness for assigned studies. 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. City: New Brunswick State: NJ Posting Number: 26ST1777
