Research Operations Manager - Pediatrics

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

Job summary

Penn State University is seeking a Research Operations Manager to lead a pediatric oncology research team, overseeing operational, regulatory, and clinical aspects of the program. You will manage regulatory staff, research nurses, and coordinators, ensuring GCP compliance and efficient execution of trials, while collaborating with investigators, sponsors, and institutional leadership.

This role emphasizes strategic planning, budget oversight, patient-centered research integration, and continuous

Qualifications

• Bachelor’s Degree and 8+ years of relevant experience, including 3+ years supervisory.
• Experience leading regulatory and clinical research operations.
• Familiarity with GCP, IRB, and sponsor communications.

Responsibilities

• Directly manage regulatory personnel, research nurses, and study coordinators to ensure optimal performance.
• Oversee adherence to Good Clinical Practice and regulatory submissions for protocols and sponsor communications.
• Oversee budget planning, staffing, and resource allocation for trials and research initiatives.
• Serve as liaison between investigators, sponsors, regulatory agencies, and institutional leadership to align priorities.
• Integrate clinical care with research protocols to enhance patient recruitment and trial efficiency.

Skills

Leadership

Team Management

Regulatory Compliance

Clinical Research

Education

Bachelor's Degree

Job description

This position is funded for 1 year(s); continuation past 1 year(s) will be based on university need, performance, and/or availability of funding.

POSITION SPECIFICS

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.

Key Responsibilities

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 disc