Senior IIT Program Manager, Oncology Trials

CU Denver; Aurora (CO); Hybrid; USD 81,000 - 103,000; Full time

Job summary

University of Colorado Cancer Center seeks an IIT Senior Manager to oversee regulatory affairs, clinical project management, and data monitoring for the Investigator-Initiated Trial program. You will define objectives with leadership and guide IIT development and study portfolio management.

The role drives policy development, program growth, and personnel management across IIT operations while collaborating across CU Anschutz entities and governance bodies.

Qualifications

• Bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field.
• 5-7 years of professional experience, including clinical research experience and experience with Investigator Initiated Trials (IITs).
• Experience with regulatory compliance, FDA/IRB/GCP knowledge is preferred.
• Budgeting, contract management, and financial oversight experience is a plus.

Responsibilities

• Oversee IIT protocol opening process; act as escalation point to resolve obstacles.
• Hold regular IIT Portfolio review meetings to assess progress and priorities.
• Oversee IIT accrual monitoring and data compilation for IIT Review Committee.
• Review IIT Site Selection and Feasibility Questionnaires and sign off.
• Review CAPA documents and ensure clear, thorough responses.

Skills

Leadership

Regulatory knowledge

Clinical research operations

People management

Communication skills

Diversity and inclusion

Education

Bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field

Tools

RedCap

Advarra EDC

eREG

Project management software

Job description

University of Colorado Cancer Center seeks an IIT Senior Manager to oversee regulatory affairs, clinical project management, and data monitoring for the Investigator-Initiated Trial program. You will define objectives with leadership and guide IIT development and study portfolio management.

The role drives policy development, program growth, and personnel management across IIT operations while collaborating across CU Anschutz entities and governance bodies.