The Program Manager (PM) supports Masonic Cancer Center (MCC) researchers through program coordination, project management, evaluation, data management, and stakeholder engagement. The role requires partnering and collaborating across multiple departments with diverse stakeholders. The PM oversees clinical trial start-up activities and lifecycle management of an assigned portfolio of studies within the MCC Clinical Trials Office (CTO). The PM ensures on-time delivery of project milestones and deliverables, effective study budget development, optimal resourcing of trials, and regular review and reporting of project and portfolio health. Excellent communication skills, stakeholder management, the ability to manage complex logistics, and an organized approach are mandatory.

KEY RESPONSIBILITIES
Clinical Trial Start-up and Management (60%)
• Lead and monitor the clinical trial activation process for assigned program portfolio. Serve as the primary point of contact to connect internal and external stakeholders during study start-up.
Maintain up-to-date tracking and status of all studies in the activation queue. Review status with faculty and project stakeholders on a regular basis to support early identification of issues that
require escalation. Proactively communicate challenges and escalate appropriately to ensure that studies are activated in a timely manner.
• Lead and participate in regular meetings with stakeholders and management to support the timeline process, review staffing needs/changes for resource availability.
• Develop budgets for all clinical trials and support central offices with budget and contract negotiations. Manage protocol amendment process. Assist with resolution of financial queries and partners with the post award staff to review budget deficits.
• Implement reporting processes to monitor and maintain activation timeline goals. Track and identify trends and opportunities for improvement across the clinical trial activation/amendment continuum.
• Assist with the development and implementation of internal communications strategies to facilitate and promote rapid protocol activation and other initiatives.

Program/Portfolio Management (40%)
• Provide concierge-level support for cancer center investigators and ISC teams. Strategize, develop and implement individual clinical research project plans for the life cycle of clinical trials. Troubleshoot requests/issues to ensure delivery of "best-in-class" service.
• Lead scheduling, planning and logistical support for assigned program/ISC meetings.
• Assist ISC team and CTO Senior Leadership Team with portfolio level study prioritization. Develop meeting materials and facilitate data collection to inform new study feasibility and to review the status of study/portfolio health. Manage workflow to prioritize resources for pending and active studies.
• Oversee completeness of CTO portfolio data tracking in OnCore (Clinical Trials Management System) and Smartsheet (lifecycle project management system).
• Manage the collection and analysis of study/portfolio/program performance metrics, as directed.
• Identify, lead, and collaborate with leadership and key stakeholders to drive targeted performance improvements. Work to modify practices and procedures to improve efficiencies across program portfolios.
• Participate in CTO interview committee and provide feedback to the hiring manager(s).
• Collaborate with internal and external stakeholders to facilitate audits; serve as liaison between the sponsor, investigator, and governing body if audits or CAPAs are requested.
• Utilize extensive knowledge and comprehension of Code of Federal Regulations (CFR), Good Clinical Practice (GCP) guidelines, and compliance with all applicable regulations and policies to oversee CTO portfolio activities.
• Actively participate in University of Minnesota research committees and team meetings.
• Other duties as assigned.

Qualifications

All required qualifications must be documented on application materials.

REQUIRED QUALIFICATIONS
• BA/BS degree plus six years of relevant work experience or advanced degree with at least four years relevant work experience.
• Education or work experience in clinical and/or translational research
• Experience working with diverse communities, organizations, and stakeholders
• Excellent verbal and written communication skills
• Strong organizational and time management skills; ability to manage competing priorities and
ensure on-time delivery of project milestones
• Experience in the management of resources and research projects
• Proficiency with computers, Google Drive, Docs, and G Suite programs and MS Word, Excel, and PowerPoint

PREFERRED QUALIFICATIONS
• Advanced degree in health, public health, or biomedical discipline
• Cancer clinical/translational research experience
• Experience leading project teams, delegating and/or assigning work tasks
• Budgeting/contracting experience
• Proficiency with OnCore and Smartsheet
• Familiarity with academic medical centers, particularly the University of Minnesota system and processes strongly preferred
• Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) certification, or equivalent (e.g., RAC)
• Experience with project management; Project Management Certification or equivalent

Pay and Benefits

Pay Range: $90,000 - $105,000 depending on education/qualifications/experience

Time Appointment: 100% Appointment

Position Type: Civil-Service & Non-Faculty Labor Represented Staff

Please visit the Office of Human Resources website for more information regarding benefit eligibility.

The University offers a comprehensive benefits package that includes:

• Competitive wages, paid holidays, and generous time off
• Continuous learning opportunities through professional training and degree-seeking programs supported by the Regents Tuition Benefit Program
• Low-cost medical, dental, and pharmacy plans
• Healthcare and dependent care flexible spending accounts
• University HSA contributions
• Disability and employer-paid life insurance
• Employee wellbeing program
• Excellent retirement plans with employer contribution
• Public Service Loan Forgiveness (PSLF) opportunity
• Financial counseling services
• Employee Assistance Program with eight sessions of counseling at no cost
• Employee Transit Pass with free or reduced rates in the Twin Cities metro area

While our salary ranges provide a framework, it is important to note that most of the
time, the initial pay may not reach the maximum of the range. This approach ensures
that compensation reflects the value and unique contributions of each candidate while
maintaining equity within our organization. As part of our commitment to fair and
equitable compensation, please be aware that the salary offered to incoming candidates
will be based on their individual credentials and experience.

How To Apply

Applications must be submitted online. To be considered for this position, please click the Apply button and follow the instructions. You will be given the opportunity to complete an online application for the position and attach a cover letter and resume.

Additional documents may be attached after application by accessing your "My Job Applications" page and uploading documents in the "My Cover Letters and Attachments" section.

To request an accommodation during the application process, please e-mail [email protected].