About the Job
OVERVIEW
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 included in the application
materials
REQUIRED QUALIFICATIONS
* BA/BS degree with at least six years of work experience or advanced degree with at
least four years work experience, or a combination of education and work experience to equal nine years
* 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
About the Department
The
Masonic Cancer Center creates a collaborative research environment focused on the causes, prevention, detection, and treatment of cancer;
applying that knowledge to improve quality of life for patients and survivors; and sharing its discoveries with other scientists, students,
professionals, and the community. Founded in 1991, MCC became a National Cancer Institute-designated comprehensive cancer center in 1998 and
is now one of only 50 institutions in the United States to hold this designation, which is awarded only to institutions that make ongoing,
significant advances in cancer research, treatment, and education. Many people choose to work at the University of Minnesota MCC because
they believe in our mission and are excited by our vision for the future. We have a reputation as a great place to work with excellent
leadership and a strong community that values diversity. The University of Minnesota provides a very competitive benefits package and access
to many resources and professional development opportunities.
Benefits
Working at the
University
At the University of Minnesota, you’ll find a flexible work environment and supportive colleagues who are
interested in lifelong learning. We prioritize work-life balance, allowing you to invest in the future of your career and in your life
outside of work.
The University also offers a comprehensive benefits package that includes:
Please visit the Office of Human Resources website for more
information regarding benefits.
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] or call (612) 624-UOHR
(8647).
Diversity
The University recognizes and values the importance of diversity and inclusion in enriching
the employment experience of its employees and in supporting the academic mission. The University is committed to attracting and retaining
employees with varying identities and backgrounds.
The University of Minnesota provides equal access to and opportunity in its
programs, facilities, and employment without regard to race, color, creed, religion, national origin, gender, age, marital status,
disability, public assistance status, veteran status, sexual orientation, gender identity, or gender expression. To learn more about
diversity at the U: http://diversity.umn.edu
Employment
Requirements
Any offer of employment is contingent upon the successful completion of a background check. Our presumption is
that prospective employees are eligible to work here. Criminal convictions do not automatically disqualify finalists from
employment.
About the U of M
The University of Minnesota, Twin Cities (UMTC)
The
University of Minnesota, Twin Cities (UMTC), is among the largest public research universities in the country, offering undergraduate,
graduate, and professional students a multitude of opportunities for study and research. Located at the heart of one of the nation’s most
vibrant, diverse metropolitan communities, students on the campuses in Minneapolis and St. Paul benefit from extensive partnerships with
world-renowned health centers, international corporations, government agencies, and arts, nonprofit, and public service
organizations.
At the University of Minnesota, we are proud to be recognized by the Star Tribune as a Top Workplace for 2021, as well
as by Forbes as Best Employers for Women and one of America’s Best Employers (2015, 2018, 2019, 2023), Best Employer for Diversity (2019,
2020), Best Employer for New Grads (2018, 2019), and Best Employer by State (2019, 2022).
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