Clinical Research Program Manager

About the Job

Working Title: Clinical Research Program Manager

Job Code Title: Research Manager 1 - Clinical Research Project Management

Job Code: 9391CP

Position Summary: The Clinical Research Program Manager provides clinical research management expertise across a diverse portfolio, including investigator-initiated, federally funded (e.g., NIH), and industry-sponsored Phase I–IV trials within the Dermatology Research Division. Collaborating closely with the Division Director, the Program Manager leads the clinical research program, manages complex studies, and drives institutional process improvement initiatives. This role requires strong analytical and technical skills, comprehensive project management expertise, and a deep understanding of clinical and laboratory processes. Additionally, the Program Manager is responsible for mentoring and guiding research staff and trainees.

Job Responsibilities

Program Management and Strategic Leadership (30%)

• Lead the Dermatology clinical research program services, working closely with the director of the Research Division on strategic planning.
• Work collaboratively with department administrative leadership to insure division success.
• Serve as an expert consultant on clinical research across multiple departments, disciplines, and/or diseases/conditions, driving institutional process improvement efforts.
• Provide professional clinical research expertise and guidance to Dermatology faculty and investigators regarding protocol feasibility, conflicts of interest, regulatory compliance, resource options, subject population, timelines, and budget.
• Oversee quality control and internal monitoring activities within the research program.
• Manage the successful research operations of the program, including leading cross-functional teams, managing timelines, budgets, and requirements using project management methodologies.
• Work collaboratively with Department research staff to facilitate weekly clinical research meetings and track action items.
• Work collaboratively with the Dermatology Finance to oversee the research portfolio budget and financial reporting.
• Compiles reports/presentations on program activity; analyzes historical data and trends; determines impact on existing and future operations.
• Represent the department in medical school, CTSI, IRB, and SPA meetings and initiatives.
• Provide staff with training of systems and processes.

Project Management (30%)

• Responsible for managing and supporting of all aspects of clinical research projects, ensuring timely delivery of results and high-quality outcomes.
• Oversees the planning, project management of clinical studies for the life-cycle of the study from site selection through study close out.

Study Coordination (20%)

Regulatory Compliance and Oversight (10%)

Supervision, and Mentorship (10%)

Qualifications

Required Qualifications:

• BA/BS in a health-related field with at least six (6) years of clinical or research experience, OR an advanced degree with at least four (4) years of clinical or research experience.
• Relevant and direct experience in clinical research to include working with the IRB, data management, and following clinical research Standard Operating Procedures (SOPs), the Code of Federal Regulations for clinical trials, and Good Clinical Practice (GCP) guidelines.
• Experience with laboratory guidelines and handling clinical research samples.
• Relevant and direct experience with regulatory requirements including study monitoring, IRB, and IND/IDE submissions.
• Proven ability to communicate effectively and clearly in both verbal and written formats.

Preferred Qualifications:

• Clinical Research Coordinator certification (e.g. CCRC).
• Experience with research databases, including RedCAP and OnCore.
• Experience reading and interpreting the scientific literature.
• Previous experience with Dermatology.
• Experience in both adult and pediatric studies.