Clinical Research Program Manager I
About The Position
The Clinical Research Program Manager I works with Steve Willi, MD, Director of the Diabetes Center, and his team. The program focuses on clinical trials to treat type 1 and type 2 diabetes in children and delay disease progression. The role autonomously oversees Dr. Willi’s research studies in the Diabetes Center for Children and provides leadership and site management for CHOP and participating study sites. The position supervises staff and provides technical expertise to operationalize studies and mentor and guide team members throughout the study lifecycle, from conception through execution and termination. It also performs clinical research coordination and oversight activities as needed.
Requirements
- Bachelor’s degree required.
- At least five years of relevant and complex research experience required.
- At least one year of leadership, management, or supervisory experience required.
- Excellent verbal and written communication skills.
- Excellent interpersonal and customer service skills.
- Excellent time-management skills.
- Strong critical-thinking and problem-solving skills.
- Strong project-management, organizational, and analytical skills.
- Solid leadership skills.
- Ability to maintain confidentiality and professionalism.
- Ability to work independently with minimal supervision.
- Ability to convey complex or technical information clearly.
- Ability to collaborate with stakeholders at all levels.
- Ability to be flexible and adaptable to change.
Nice To Haves
- Master’s degree in a related field preferred.
- At least seven years of relevant and complex research experience preferred.
- At least three years of leadership, management, or supervisory experience in a clinical research or academic environment preferred.
- At least three years of research administration or management experience, including budget administration, financial planning, and grants management preferred.
Responsibilities
- Supervise, train, support, and manage staff to ensure compliance with study protocols and NIH and FDA policies.
- Collaborate with study management teams, CHOP Research Institute core groups, and participating institutions.
- Develop, review, and update program policies and procedures as part of the management team.
- Serve as the primary liaison between research and other hospital staff to meet research project needs.
- Assist with data analysis and preparation of manuscripts and scientific presentations as needed.
- Track regulatory compliance at CHOP and other participating sites.
- Oversee financial resources, create internal and external research protocol budgets, ensure financial accountability, and liaise with sponsors, department accounting, and Research.
- Apply Good Clinical Practice guidelines and relevant regulations concerning human research protections, pediatric research, adverse-event reporting, informed consent, and clinical trials.
- Provide supervision and support to clinical research coordinators and monitors assigned to protocols.
- Lead the development, implementation, and evaluation of clinical research conduct.
- Ensure regulatory compliance for the clinical research program.
- Evaluate staffing, financial, and regulatory decisions throughout the study lifecycle.
- Prepare or oversee preparation of Data Safety Monitoring Board reports, as needed.
- Serve as the primary trial contact for internal and external participants.
Benefits
- Eligible for an incentive program.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
