Program Manager, Early Therapeutics/Phase 1 (University of Arizona Cancer Center) (Full-time)

The University of Arizona Cancer Center (UACC) is a National Cancer Institute-designated Comprehensive Cancer Center committed to preventing and curing cancer through exceptional patient care, groundbreaking research, and comprehensive education.

The Early Therapeutics/Phase 1 Program at the University of Arizona Cancer Center (UACC) is seeking a Program Manager. This position contributes to the organization, development, and sponsor management activities of clinical and translational research, and is primarily focused on industry partner relations, trial activation, and regulatory/data management. This position collaborates with physicians and research collaborators, cancer center shared resources, and Phase 1 Clinical Research Team (CRT) leadership. This role will help develop protocol reports and provide sponsor management activities including appropriate communication with all participating sites as well as UA and UACC oversight committees. The person will also provide dedicated strategic support for clinical trials within the Phase 1 CRT. The selected candidate/s will work closely with clinical faculty and the assigned disease team, have regular contact with investigators, regulatory staff, clinical trials sponsors (e.g. private industry and national cooperative groups), and administrative staff.

Outstanding UA benefits include health, dental, and vision insurance plans; life insurance and disability programs; paid vacation, sick leave, and holidays; UA/ASU/NAU tuition reduction for the employee and qualified family members; retirement plans; access to UA recreation and cultural activities; and more!

The University of Arizona has been recognized for our innovative work-life programs.

Program Strategy, Growth & Operational Oversight:

• Lead the growth of the Phase 1 program by developing and maintaining effective relationships with industry partners and clinical research physicians, ensuring alignment with program objectives and long-term strategic goals.
• Oversee compliance with financial sponsor, IRB, university, UACC, and third-party regulations and policies, providing guidance to staff on policy interpretation and ensuring program-wide adherence.
• Plan, coordinate, and facilitate Phase 1 team meetings, ensuring key stakeholders are informed of program updates, action items are tracked, and decisions are documented for leadership review.
• Monitor and evaluate program performance, including goals, deadlines, budgets, and expenditures, and recommend adjustments to improve efficiency, resource utilization, and overall program outcomes.
• Maintain and communicate up-to-date knowledge of legislation, rules, regulations, and policies, providing proactive guidance to physicians and staff to ensure consistent compliance and informed decision-making.

Trial Activation & Progress Management:

• Coordinate trial activation across sponsors, university departments, and Banner Health partners, identify and addressing barriers proactively, and ensuring smooth, timely trial initiation.
• Analyze and report trial activation and progress metrics to CTO leadership and assigned Disease Teams, providing insights and recommendations to enhance operational efficiency and program performance.

Trial & Participant Coordination

• Facilitate trial participation by serving as the primary point of contact for communications with industry partners; work with the CRC team to ensure timely and accurate completion of consent forms; case report forms; and other ancillary material (i.e., research subject telephone scripts, instructional guides, and research manuals) and revise/amend existing documents as necessary.
• Assist in trial recruitment (i.e., fielding participant referrals), portfolio management, and trial startup/maintenance activities.
• Provide support for resolving operational, workload, protocol implementation, and data collection issues.
• Ensure that open trials are progressing appropriately towards accrual goals.
• Identifies any potential risks and challenges in the Phase 1 program. Works collaboratively with PIs and CTO leadership to find solutions and develop an implementation plan to address issues.

Sponsor & Patient Liaison Responsibilities

• Serve as a liaison between the disease team and study sponsor as a representative of the University of Arizona Cancer Center to foster productive relationships.
• Remain knowledgeable about the patient population being seen within the clinics and actively participate in identifying trials that meet the research needs of the patient population.
• Serve as a back-up to the CRC team and assist the team as needed in tasks such as interviewing and evaluating potential participants to ensure they meet eligibility requirements, scheduling appointments for study participants, instructing participants regarding protocol, and obtaining consent signatures.

Data Management & Patient Safety Oversight

• Develop and/or coordinate the database specifications, edit check specifications, and the development of a documented trial data management plan, conduct data reviews, query generation/resolution, data reconciliation, and help identify protocol deviations.
• Actively participate in disease team meetings and collaborate with Banner clinic staff and clinical trials office staff to ensure patient safety and adherence to the protocol requirements.

Knowledge, Skills, and Abilities:

• Project coordination and time management to manage program activities within deadlines.
• Problem-solving and adaptability to address technical and operational challenges efficiently.
• Collaboration and interpersonal skills to work effectively with a variety of partners, both internal and external.
• Strong written and verbal communication.
• Knowledge of clinical research regulations.
• Regulatory and document management skills.