Assoc. Dir Research Operations (Operations Manager/Scientist)

Position Details

Position Information

Recruitment/Posting Title Assoc. Dir Research Operations (Operations Manager/Scientist) Job Category Staff & Executive - Executive Department Clinical & Translational R Overview

The Rutgers Contract Research Collaboratory (RCRC) is a newly established center within the Rutgers Institute for Translational Medicine & Science (RITMS) that is building a premier Contract Research Organization dedicated to advancing multi-site clinical trials, observational studies, and translational research across Rutgers Health and its national partners.

RCRC brings together expertise in clinical research, biostatistics, data management, project management, and scientific leadership to deliver innovative, high-quality research solutions for academic, government, and industry sponsors. By leveraging advanced data technologies, collaborative partnerships, and operational excellence, RCRC is positioning Rutgers Health as a national leader in clinical trial coordination and data science while offering exceptional career opportunities for professionals committed to accelerating research discoveries and improving patient outcomes.

What will make RCRC different is our intentional commitment to building an organization where talented professionals are challenged, supported, and trusted to grow while performing meaningful work at the highest level. We seek individuals who think strategically, embrace collaboration, take ownership beyond their job descriptions, and continuously improve the systems and people around them. We value intellectual curiosity, humility, accountability, and a commitment to excellence. In return, RCRC offers accessible leadership, meaningful professional development, and the opportunity to help build a nationally recognized model for clinical research excellence.

Our Mission: To transform clinical research through dedicated partnerships, efficient execution, and uncompromising quality.

Our Vision: To build a contract research organization where exceptional people come together to do their best work, partnering closely with sponsors to deliver research that is streamlined, thoughtful, and trusted. We envision a collaborative environment where individuals think beyond their defined roles, teams share ownership of outcomes, and innovation drives continuous improvement in clinical research. Through this approach, we strive to create a more efficient and accessible research ecosystem that produces better outcomes for sponsors, healthcare providers, and ultimately, patients.

Posting Summary

Rutgers, The State University of New Jersey is seeking an Associate Director Research Operations (Operations Manager/Scientist) within the Rutgers Contract Research Collaboratory (RCRC) Division of the Rutgers Institute for Translational Medicine and Science (RITMS).

The Associate Director, Research Operations will serve as a strategic partner to the Director in establishing, growing, and continuously improving the Rutgers Contract Research Collaboratory (RCRC). This individual will provide scientific, operational, and regulatory leadership across a diverse portfolio of industry-sponsored, federally funded, and investigator-initiated clinical research programs, translating sponsor clinical development objectives into high-quality, compliant, and efficiently executed studies.

Working collaboratively with investigators, sponsors, institutional leadership, and multidisciplinary research teams, the Associate Director will oversee portfolio planning, study feasibility, operational strategy, resource allocation, staffing, budget development, vendor management, and performance monitoring. The successful candidate will help develop standardized operating procedures, quality management systems, and operational metrics that promote efficiency, consistency, regulatory compliance, and continuous process improvement across the organization.

The Associate Director will play a central role in sponsor engagement and business development by supporting proposal development, protocol feasibility assessments, and strategic partnerships while ensuring studies are delivered on time, within budget, and to the highest scientific and regulatory standards. The position requires extensive knowledge of FDA regulations, ICH-Good Clinical Practice (ICH-GCP), IND and IDE studies, and the regulatory requirements governing multi-site clinical research.

As a member of the RCRC leadership team, the Associate Director will recruit, mentor, and develop high-performing staff while fostering a collaborative, inclusive, and accountable culture focused on innovation, professional development, and exceptional customer service. The individual will work closely with project management, clinical data management, biostatistics, regulatory affairs, and scientific leadership to build an integrated Contract Research Organization capable of supporting complex national and international clinical research programs. As a founding leader of RCRC, the Associate Director will have a unique opportunity to shape the center's strategic direction, operational infrastructure, and organizational culture while contributing to Rutgers Health's vision of becoming a national leader in clinical research coordination and translational science.

Essential Duties and Responsibilities include the following:

• Serves as a senior sponsor-facing representative of the Rutgers Contract Research Collaboratory, supporting sponsor engagement, needs assessments, proposal development, scope-of-work development, budget strategies, bid-defense preparation and implementation, sponsor governance meetings, and identification of repeat or add-on opportunities.
• Oversees Rutgers Contract Research Collaboratory portfolio-level planning and execution in collaboration with the Director, including prioritization of studies, staffing models, workload distribution, operating budgets, vendor decisions, financial performance, and escalation of major scientific, operational, regulatory, or financial risks.
• Leads cross-functional project teams and governance discussions across sponsors, Rutgers stakeholders, investigators, vendors, and operational staff.
• Provides scientific and regulatory strategy support for industry-sponsored drug and device studies, including studies conducted under IND and IDE frameworks; advise sponsors and Rutgers teams on protocol gaps, execution risks, and practical options to improve study quality and feasibility.
• Drafts, critically review, or oversee scientific, operational, and regulatory documents, which may include protocols, synopses, project bids, informed consent templates, study manuals, clinical study reports, regulatory responses, sponsor presentations, standard operating procedures, and other study-specific materials.
• Partners with sponsors, investigators, regulatory experts, biostatistics, data management, clinical operations, and quality teams to ensure that study design and execution plans are aligned with applicable FDA, ICH GCP, institutional, and international requirements
• Oversees the development, implementation, and continuous improvement of the Rutgers Contract Research Collaboratory's clinical research quality system, including SOP architecture, controlled documents, training expectations, audit/inspection readiness, issue escalation, CAPA processes, and risk-based quality management.
• Provides strategic oversight and management to Clinical Study Managers and other operational staff responsible for study start-up, activation, site feasibility, IRB/regulatory submissions, vendor coordination, study conduct, and closeout.
• Responsible for the hiring, firing, performance review and training of the research staff.

FLSA Exempt Grade 35S Salary Details Minimum Salary 134982.000 Mid Range Salary 170754.000 Maximum Salary 206525.000 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 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, 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

• Advanced degree (PhD, PharmD, MD, or master's degree) in a relevant scientific discipline.
• Minimum 10 years' clinical research experience within a regulatory agency (e.g., FDA), in the pharmaceutical, biotechnology, or CRO industry. Alternatively, academic clinical research experience with some industry/CRO experience.
• Two (2) years of relevant supervisory experience.
• Hands-on experience supporting regulated industry-sponsored clinical trials, including drug and/or device studies conducted under IND and/or IDE frameworks.

Certifications/Licenses Required Knowledge, Skills, and Abilities

• Strong knowledge of ICH and US regulatory requirements (IND, IDE, NDA, etc.).
• Familiarity with CRO business processes, including sponsor intake, feasibility assessment, proposal development, scopes of work, clinical trial budgets, change-order concepts, and bid-defense preparation.
• Demonstrated ability to draft and review scientific documents, including protocols and study reports.
• Excellent scientific writing, presentation, negotiation, document reviews, and executive communication skills.
• Strong organizational skills with the ability to manage multiple projects and priorities.
• High attention to detail and commitment to quality.
• Ability to lead in a complex matrixed academic medical center environment while maintaining a sponsor-focused, service-oriented, high-accountability operating model.

Preferred Qualifications

• Experience designing or scaling clinical research infrastructure, including SOP development, quality systems, staffing models, service lines, metrics, and portfolio governance.
• Experience preparing for or supporting sponsor audits, internal audits, FDA inspections, EMA or other health authority inspections, CAPAs, and inspection-readiness programs.
• Global clinical research experience and familiarity with international regulatory expectations.
• Deep understanding of ICH GCP, FDA, and international regulatory guidelines.

Equipment Utilized Physical Demands and Work Environment

PHYSICAL DEMANDS:

• Standing, sitting, walking, speaking and hearing.
• No special vision requirements.

WORK ENVIRONMENT:

• Office environment. Moderate noise.

Special Conditions

Posting Details

Posting Number 26ST1540 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.

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

Supplemental Questions

Required fields are indicated with an asterisk (*).

• • Do have an advanced degree (PhD, PharmD, MD, or master's degree) in a relevant scientific discipline?

• Yes

• No

• • Do you have a minimum of 10 years of clinical research experience gained through one or more of the following settings: a regulatory agency (e.g., FDA), the pharmaceutical industry, the biotechnology industry, a CRO, or a combination of academic clinical research and industry/CRO experience?

• Yes

• No

• • Do you have at least two (2) years of relevant supervisory experience?

• Yes

• No

Applicant Documents

Required Documents

• Resume/CV

Optional Documents

• Cover Letter/Letter of Application
• List of Professional References (contact Info)