Clinical Study Manager I

Rutgers University; New Brunswick (NJ); Hybrid; USD 79,000 - 121,000; Full time

Benefits offered by this job

Medical coverage

Paid time off

Retirement benefits

Educational benefits

Life insurance

Employee discounts

Job summary

Rutgers University in New Brunswick, NJ, seeks an experienced Clinical Study Manager I to lead operational delivery of multi-site clinical and translational research studies within the Rutgers Contract Research Collaboratory (RCRC). You will coordinate investigators, sponsors, sites, vendors, and data managers throughout study lifecycle.

The role emphasizes start-up through closeout, risk management, timelines, and regulatory compliance, with hybrid work options.

Qualifications

• Bachelor’s degree in clinical research, health sciences, or related field.
• Minimum five years of relevant clinical research or project management experience.
• One year of Clinical Study Manager experience required.
• Knowledge of GCP, regulations, and TMF/eTMF systems.
• Experience managing multicenter trials and sponsors.
• Experience with risk mitigation and study oversight.
• Clinical Research Professional certification preferred.
• Experience in academic medical centers, CROs, pharma.

Responsibilities

• Manage operational execution of assigned studies from start-up through closeout and reporting.
• Serve as the primary day-to-day operational lead for assigned studies.
• Collaborate with investigators, sponsors, sites, vendors, biostatisticians, data managers, regulatory personnel, and others.
• Develop and maintain study timelines, plans, risk registers, and communication tools.
• Facilitate study team meetings and ensure timely deliverables.

Skills

GCP knowledge

Stakeholder management

Communication

Attention to detail

Project management

Multicenter trials

Education

Bachelor's degree in Clinical Research, Health Sciences, Public Health, Nursing, Biological Sciences, Healthcare Administration, Business Administration, or related field

Job description

Position Details

Recruitment/Posting Title: Clinical Study Manager I

Job Category: Staff & Executive - Research (Laboratory/Non-Laboratory)

Department: Clinical & Translational R

Overview: 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.

• 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.

• 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: Exempt

Grade: 24S

Minimum Salary: 78910.000

Mid Range Salary: 99823.000

Maximum Salary: 120736.000

Offer Information: The final salary offer may be determined by several factors, including, but not limited to, the candidate's qualifications, experience, and expertise, and availability of department or grant funds to support the position. We also take into consideration market benchmarks, if and when appropriate, and internal equity to ensure fair compensation relative to the university's broader compensation structure. We are committed to offering competitive and flexible compensation packages to attract and retain top talent.

• 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

Standard Hours: 37.50

Daily Work Shift: Day

Work 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 UMD

Payroll Designation: PeopleSoft

Terms of Appointment: Staff - 12 month

Position Pension Eligibility: ABP

Qualifications

• 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.

• 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.

• 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.

Posting Details

Posting Number: 26ST1892

Regional Campus: Rutgers Biomedical and Health Sciences (RBHS)

Home Location Campus: Downtown New Brunswick

City: New Brunswick

State: NJ

Pre-employment Screenings

All offers of employment are contingent upon successful completion of all pre-employment screenings.

Immunization Requirements

Under Policy 100.3.1 Immunization Policy for Covered Individuals, if employment will commence during Flu Season, Rutgers University may require certain prospective employees to provide proof that they are vaccinated against Seasonal Influenza for the current Flu Season, unless the University has granted the individual a medical or religious exemption. Additional infection control and safety policies may apply. Prospective employees should speak with their hiring manager to determine which policies apply to the role or position for which they are applying. Failure to provide proof of vaccination for any required vaccines or obtain a medical or religious exemption from the University will result in rescission of a candidate's offer of employment or disciplinary action up to and including termination.

Equal Employment Opportunity Statement

It is university policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, affectional or sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As an institution, we encourage all qualified applicants to apply. For additional information please see the Non-Discrimination Statement at the following web address: http://uhr.rutgers.edu/non-discrimination-statement