Position Details

Position Information

Recruitment/Posting Title
Clinical Study Manager I

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

Department
Clinical & Translational R

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
Exempt

Grade
24S

Salary Details

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.

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
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

Seniority Unit

Terms of Appointment
Staff - 12 month

Position Pension Eligibility
ABP

Qualifications

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.

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.

Equipment Utilized

Physical Demands and Work Environment

Special Conditions

Posting Details

Posting Number
26ST1892

Posting Open Date

Special Instructions to Applicants

Regional Campus
Rutgers Biomedical and Health Sciences (RBHS)

Home Location Campus
Downtown New Brunswick

City
New Brunswick

State
NJ

Location Details

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.