Clinical Trials Program Manager

Clinical Trials Program Manager

Clinical Trials Program Manager - 40056 University Staff

Description

University of Colorado Anschutz Medical Campus

Department: Medicine - Division of Cardiology

Job Title: Clinical Trials Program Manager

Position #: 00804283 - Requisition #: 40056

Job Summary:

We are seeking a Clinical Trials Program Manager in the areas of interventional cardiology and imaging research, electrophysiology, and heart failure. This position will support multiple Industry Supported Clinical Trials, Federally Funded Clinical Trials, and Investigator Initiated Clinical Trials. This position focuses primarily on the responsibility of managing the daily operations of the Cardiology Clinical Trials Program within the Division of Cardiology. This position will manage a team of research coordinators and will be responsible for ensuring that deadlines and goals are being appropriately met. The amount of time spent on required tasks may shift depending on the needs of the department.

Key Responsibilities:

• Manage and supervise Clinical Research Coordinators and PRAs, including workload distribution, training, mentoring, hiring, and performance evaluations.
• Conduct audits of study documentation and maintain SOPs, training materials, and operational processes to ensure compliance and program efficiency.
• Serve as the primary liaison for industry sponsors, university and hospital partners, and other key stakeholders across all clinical trial activities.
• Oversee clinical trial operations within the Division of Cardiology, including feasibility assessments, study tracking, enrollment monitoring, data oversight, and issue resolution.
• Support investigator-initiated trials through protocol development, case report form preparation, subject recruitment oversight, and regulatory guidance.
• Ensure compliance with Good Clinical Practice (GCP), institutional policies, FDA regulations, sponsor audits, and safety standards across all research activities.
• Direct operational and financial management activities, including budgeting, resource allocation, funding distribution, infrastructure improvements, and cross-functional team leadership.

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 4 days per week on campus and as needed for in-person meetings.