Research Operations Manager - Pediatrics

The Pennsylvania State University; United States; On-site; USD 103,000 - 154,000; Full time

Benefits offered by this job

75% tuition discount

Comprehensive benefits package

Paid time off (holidays, vacation, and

Job summary

The Pennsylvania State University is seeking a Research Operations Manager to lead a pediatric oncology research team focused on experimental therapeutics. The role oversees operational, regulatory, and clinical aspects of the program, ensuring compliance, efficiency, and innovation.

You will supervise regulatory specialists, research nurses, and coordinators while coordinating with sponsors and institutional leadership.

Qualifications

• Bachelor’s degree and 8+ years of relevant experience, including 3+ years of supervisory experience.
• Experience leading regulatory staff and clinical operations in research settings.
• Knowledge of Good Clinical Practice (GCP) and regulatory requirements.

Responsibilities

• Directly manage a diverse research team, including regulatory personnel, research nurses, and study coordinators.
• Oversee budgeting, financial analysis, and resource allocation for clinical trials and research initiatives.
• Ensure submission of regulatory documents, IRB protocols, and sponsor communications in a timely manner.
• Develop policies and procedures to improve research efficiency, regulatory compliance, and patient safety.
• Liaise with investigators, sponsors, regulatory agencies, and institutional leadership to align operations with goals.
• Coordinate integration of clinical care with research protocols and strategies to improve patient recruitment and trial performance.

Skills

Leadership

Team management

Regulatory compliance

Budgeting

Stakeholder collaboration

Education

Bachelor’s Degree

Job description

Position Overview

The Research Operations Manager will lead a pioneering pediatric oncology research team at the forefront of experimental therapeutics while fostering a dynamic, collaborative, and patient-centered research environment. This role is responsible for managing the operational, regulatory, and clinical aspects of the research program, ensuring the highest standards of compliance, efficiency, and innovation. The manager will oversee a team of regulatory specialists, research nurses, and coordinators, while serving as a key liaison between research teams, clinical partners, external sponsors, and institutional leadership.

Leadership & Team Management

• Directly manage a diverse research team, including regulatory personnel, research nurses, and study coordinators, ensuring optimal team performance and professional development.
• Provide mentorship, guidance, and training to staff, fostering a culture of excellence, collaboration, and continuous improvement.
• Oversee staffing, workload distribution, performance evaluations, and employee development in collaboration with HR.

Research Operations & Compliance

• Lead the execution of experimental therapeutic clinical trials, ensuring adherence to Good Clinical Practice (GCP) and institutional, state, and federal regulations.
• Develop, implement, and refine policies and procedures to enhance research efficiency, regulatory compliance, and patient safety.
• Ensure accurate and timely submission of regulatory documents, IRB protocols, and sponsor communications.
• Collaborate with investigators and stakeholders to develop new research initiatives, optimize study design, and troubleshoot operational challenges.

Financial & Resource Management

• Oversee budget planning, financial analysis, and resource allocation to support clinical trials and research initiatives.
• Work closely with financial officers to monitor funding, salary allocations, and research expenditures.

Strategic Planning & Stakeholder Collaboration

• Serve as liaison between investigators, industry sponsors, regulatory agencies, and institutional leadership.
• Lead strategic planning initiatives to align research operations with institutional goals, driving innovation and program growth.
• Develop key performance indicators (KPIs) and metrics to evaluate program success and identify areas for improvement.
• Represent the research team in institutional committees, working groups, and strategic discussions to advocate for program needs and expansion.

Patient-Centered Research & Clinical Integration

• Ensure seamless integration between clinical care and research protocols, maintaining a patient-centered approach to trial execution.
• Develop and implement strategies to enhance patient recruitment, retention, and overall trial efficiency.
• Address operational challenges and implement process improvements to support high-quality, ethical, and effective clinical research.

Minimum Education, Work Experience & Required Certifications

• Bachelor’s Degree 8+ years of relevant experience, includes 3+ years of supervisory experience; or an equivalent combination of education and experience accepted
• Required Certifications: None

Background Checks/Clearances

• Employment with the University will require successful completion of background check(s) in accordance with University policies.
• Penn State does not sponsor or take over sponsorship of a staff employment Visa.
• Applicants must be authorized to work in the U.S.

Salary & Benefits

The salary range for this position, including all possible grades, is $102,936.00 - $154,452.00.

Salary Structure - Information on Penn State's salary structure

• Penn State provides a competitive benefits package for full-time employees designed to support both personal and professional well-being.
• In addition to comprehensive medical, dental, and vision coverage, employees enjoy robust retirement plans and substantial paid time off which includes holidays, vacation and sick time.
• One of the standout benefits is the generous 75% tuition discount, available to employees as well as eligible spouses and children.

EEO IS THE LAW

Penn State is an equal opportunity employer and is committed to providing employment opportunities to all qualified applicants without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If you are unable to use our online application process due to an impairment or disability, please contact 814-865-1473.

Penn State is committed to and accountable for advancing equity, respect, and belonging. We embrace individual uniqueness, as well as a culture of belonging that supports equity initiatives, leverages the educational and institutional benefits of inclusion in society, and provides opportunities for engagement intended to help all members of the community thrive. We value belonging as a core strength and an essential element of the university’s teaching, research, and service mission.

Our values are as follows; Integrity, Respect, Responsibility, Discovery, Excellence, and Community.

We Are Penn State. One Community. Impacting Many.