About the position
The Penn State College of Medicine, Department of Pediatrics, in Hershey, PA, is seeking a Research Operations Manager. 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 11, including regulatory specialists, research nurses, and coordinators, while serving as a key liaison between research teams, clinical partners, external sponsors, and institutional leadership. This position will be hired at a manager level.
Responsibilities
- 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.
- 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.
- 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.
- 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.
- 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.
Requirements
- Bachelor's Degree
- 8+ years of relevant experience, includes 3+ years of supervisory experience
- An equivalent combination of education and experience accepted
Benefits
- Salary range: $86,300.00 - $129,500.00
