Clinical Research Program Manager

About the role

The Clinical Research Program Manager will oversee all Castleman disease (CD) clinical research programs, including the CD ACCELERATE natural history registry and CD biobank, Castlebank. This role will be integral to the strategic planning and establishment of the CSTL, integrating clinical, research, educational, and patient advocacy operations.

Responsibilities

• Ensure protocols, SOPs, regulatory guidelines, GCP, and best practices are followed rigorously.
• Work closely with internal and external stakeholders to ensure regulatory compliance, completion of project milestones, and reporting requirements.
• Manage oversight of a clinical trial, including recruitment, patient visits, blood draws, documentation, data entry, and IRB submissions.
• Directly manage a research team (2 data analysts, coordinator, and assistants).
• Coordinate the preparation and submission of regulatory documents (continuing reviews, amendments, adverse event reports) to the IRB and other regulatory bodies.
• Perform quality auditing and adverse event reporting, and work with IRBs and foreign ethics committees.
• Manage the database, perform quality auditing, and assist with the orientation, training, and supervision of data analysts, coordinators, and student workers.

Qualifications

• Bachelor's Degree with 5-7 years of related experience or equivalent combination of education and experience.
• Master’s degree in a health-related discipline plus 3-5 years relevant clinical research experience preferred.
• Experience with research planning, operations, and project management.
• Strong organizational skills; experience conducting studies in hematology/oncology, immunology, clinical trials, and registries preferred.
• Excellent verbal and written communication skills.
• Proficiency in MS Word and Excel applications.
• Thorough knowledge of Federal Regulations, GCP, and IND/IDE in research.
• Understanding of regulatory affairs and their applications to Quality Control and Quality Assurance.
• Effective problem-solving abilities; ability to multi-task and prioritize; strong work ethic; ability to work independently and as part of a team; excellent organizational and time management skills.

Skills

• Strong leadership and management skills.
• Experience in clinical research is a plus.

Benefits

The University of Pennsylvania offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, professional development opportunities, supportive work and family benefits, health and wellness programs, and much more.

Pay

$75,804.00 - $81,441.00 Annual Rate

Schedule

Full-time, Monday through Friday, 8:30 AM – 5:00 PM. Position contingent to funding.