Clinical Study Manager I

Department: Clinical & Translational ROverview - The Rutgers Contract Research Collaboratory (RCRC), a newly established center within the Rutgers Institute for Translational Medicine & Science (RITMS), is building a premier Contract Research Organization (CRO) dedicated to advancing multi-site clinical trials, observational studies, and translational research. Serving industry, academic, and government sponsors, RCRC integrates expertise in clinical research, biostatistics, data management, project management, and scientific leadership to deliver innovative, high-quality research solutions that accelerate discoveries and improve patient outcomes. What sets RCRC apart is our commitment to building an organization where exceptional professionals are challenged, supported, and empowered to grow while performing meaningful work. We seek individuals who think strategically, collaborate across disciplines, take ownership beyond their defined roles, and continuously improve the systems and teams around them. We value intellectual curiosity, accountability, humility, and excellence.

Our Mission: Transform clinical research through dedicated partnerships, efficient execution, and uncompromising quality, driven by deeply engaged teams.

Our Vision: To build a contract research organization where exceptional people come together to do their best work, partnering deeply with sponsors to deliver research that is streamlined, thoughtful, and trusted. We envision a model where individuals think beyond their roles, teams are fully engaged, and the organization takes shared ownership of outcomes, challenging convention and continuously improving how research is done. Through this approach, we aim to contribute to a more efficient and accessible research ecosystem, where strong collaboration, sound science, and purposeful execution lead to better outcomes for sponsors, providers, and ultimately, for patients. Posting Summary - Rutgers, The State University of New Jersey, is seeking an experienced Clinical Study Manager I, within the Rutgers Contract Research Collaboratory (RCRC), part of the Rutgers Institute for Translational Medicine and Science (RITMS). Clinical Study Manager I will support innovative clinical and translational research programs. This position offers the opportunity to collaborate with investigators, sponsors, research sites, vendors, 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.

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.

FLSA: ExemptGrade - 24SSalary Details

Benefits: Rutgers provides a comprehensive benefits package to eligible employees. The specific benefits vary based on the position and may include: Medical, prescription drug, and dental coverage Paid vacation, holidays, and various leave programs Competitive retirement benefits, including defined contribution plans and voluntary tax-deferred savings options Employee and dependent educational benefits (when applicable) Life insurance coverage Employee discount programs Position Status - Full Time Working Hours

Standard Hours: 37.50 Daily Work Shift - DayWork Arrangement - Consistent with the current application of Rutgers Policy 60.3.22 or the applicable provisions of relevant collective negotiations agreements, this position may be eligible for a hybrid work arrangement. Flexible work arrangements are not permanent, are subject to change or discontinuation, and contingent on the employee receiving approval in the FlexWork@RU Application System. Union Description - MPSC - Legacy UMDPayroll Designation - PeopleSoftSeniority UnitTerms of Appointment - Staff - 12 month Position Pension Eligibility - ABPQualificationsMinimum 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.

Certifications/Licenses: Required Knowledge, Skills, and Abilities - Demonstrated ability to independently manage clinical research studies or complex project workstreams. Working knowledge of Good Clinical Practice (GCP), human subject research regulations, and clinical research operations. Demonstrated ability to manage competing priorities and multiple stakeholders. Strong organizational, problem-solving, and decision-making skills. Excellent written and verbal communication skills. High attention to detail and commitment to quality. Familiarity with Trial Master File (TMF) or electronic Trial Master File (eTMF) systems.

Preferred Qualifications: Experience managing multicenter clinical trials or complex clinical research programs. Experience maintaining oversight of Trial Master Files (TMFs) and inspection readiness activities. Experience developing or implementing risk mitigation plans. Experience interacting directly with sponsors, investigators, sites, and external vendors. Clinical Research Professional certification (e.g., CCRP, CCRC, ACRP-CP). Experience within an academic medical center, CRO, pharmaceutical, or biotechnology environment. Experience contributing to process improvement, operational excellence, or study management best practice initiatives.