Position DetailsPosition Information
Recruitment/Posting Title RCRC Clinical Data 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 a Clinical Data Manager I to support innovative clinical and translational research programs within the Rutgers Contract Research Collaboratory (RCRC), part of the Rutgers Institute for Translational Medicine and Science (RITMS).
The Clinical Data Manager I position offers the opportunity to collaborate with investigators, sponsors, clinical study managers, biostatisticians, research sites, vendors, and regulatory personnel while contributing to database development, data quality oversight, study execution, regulatory compliance, and reporting activities. The successful candidate will serve as the primary Clinical Data Manager for assigned studies and be accountable for study-level data management execution, database readiness, data quality oversight, and delivery of data management objectives throughout the study lifecycle. The individual will be responsible for overseeing data quality, coordinating data management deliverables, managing stakeholders, and ensuring study data is accurate, complete, consistent, and fit for scientific analysis and decision-making.
Responsibilities include:- Accountable for study-level clinical data management activities from study start-up through database lock and study closeout.
- Serves as the primary Clinical Data Manager and principal point of contact for assigned studies.
- Collaborates with investigators, sponsors, clinical study managers, biostatisticians, sites, vendors, and regulatory personnel throughout the research lifecycle.
- Contributes to database design, testing, validation, implementation, and maintenance activities to support study objectives.
- Develops and maintains study-specific data management plans, data review plans, reconciliation strategies, and database lock readiness activities.
- Oversees data review, query management, data reconciliation, and issue resolution activities to ensure high-quality study data.
- Monitors study data quality, identifies risks and trends, and implements corrective actions when necessary.
- Leads database lock preparation and coordinates activities necessary to achieve analysis-ready datasets.
- Ensures data management deliverables, documentation, and study records are complete, compliant, and inspection ready.
- Contributes to continuous improvement initiatives and advancement of data management best practices.
- Participates in mentoring, onboarding, coaching, and knowledge-sharing activities that support development of the Clinical Data Management function.
- Pursues ongoing professional development and growth within clinical data management.
Essential Functions:- Serves as the primary day-to-day Clinical Data Manager for assigned clinical and translational research studies.
- Accountable for study-level data management execution, deliverables, timelines, data quality outcomes, and database readiness.
- Oversees data review, query management, data reconciliation, and discrepancy resolution activities to ensure study data are accurate, complete, consistent, and fit for analysis.
- Supports database design, testing, implementation, validation, and maintenance activities throughout the study lifecycle.
- Ensures study data management documentation, records, and deliverables are complete, accurate, compliant, and inspection ready.
- Facilitates collaboration among investigators, sponsors, clinical study managers, sites, vendors, biostatisticians, and other stakeholders to resolve data-related issues and supports study objectives.
- Identifies data quality risks, develop mitigation strategies, and implement corrective actions to support successful study execution.
- Leads database lock preparation and coordinates cross-functional activities necessary to achieve database lock and analysis-ready datasets.
- Provides guidance, onboarding support, mentoring, and knowledge sharing to less experienced Clinical Data Management staff.
- Contributes to continuous improvement initiatives that strengthen study execution, data quality, and Clinical Data Management practices.
FLSA Exempt
Grade 25S
Salary DetailsMinimum Salary 82856.000
Mid Range Salary 104816.000
Maximum Salary 126775.000
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 HoursStandard Hours 37.50
Daily Work ShiftWork 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 UnitTerms of Appointment Staff - 12 month
Position Pension Eligibility ABP
Qualifications
Minimum Education and Experience - Bachelor's degree in Clinical Research, Health Sciences, Public Health, Statistics, Information Systems, Data Science, Biological Sciences, or a related field.
- Minimum 5 years of relevant clinical research, data management, database administration, or research operations experience.
Certifications/LicensesRequired Knowledge, Skills, and Abilities - Demonstrated ability to independently manage clinical data management activities for research studies.
- Strong knowledge of clinical research operations, Good Clinical Practice (GCP), and clinical data management principles.
- Experience with electronic data capture (EDC) systems, database testing, validation, and study implementation activities.
- Demonstrated ability to oversee data quality review activities and manage complex data issues.
- Strong analytical, problem-solving, organizational, and decision-making skills.
- Excellent written and verbal communication skills.
- High attention to detail and commitment to data quality and integrity.
Preferred Qualifications - Experience managing data management activities for multicenter clinical trials or complex clinical research programs.
- Experience coordinating database lock activities and preparation of analysis-ready datasets.
- Experience with clinical data standards (e.g., CDISC SDTM, ADaM), external data reconciliations, and inspection-ready study documentation.
- Certified Clinical Data Manager (CCDM), Clinical Research Professional certification (e.g., CCRP, CCRC, ACRP-CP), or equivalent professional certification.
- Experience within an academic medical center, CRO, pharmaceutical, or biotechnology environment.
Equipment UtilizedPhysical Demands and Work Environment - PHYSICAL DEMANDS: Standing, sitting, walking, speaking and hearing. No special vision requirements.
- WORK ENVIRONMENT: Office environment. Moderate noise.
Special ConditionsPosting Details
Posting Number 26ST2090
Posting Open DateSpecial Instructions to ApplicantsRegional Campus Rutgers Biomedical and Health Sciences (RBHS)
Home Location Campus Downtown New Brunswick
City New Brunswick
State NJ
Location DetailsPre-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.
