Clinical Science Program Manager, GN Trials

Job Summary:

The Renal Division has a robust clinical trials program with its own dedicated space for administrative and clinical operations. This particular position offers the opportunity to lead and manage all aspects of approximately 8 trials (from interventional treatment to biobank) for rare inflammatory kidney disease (glomerulonephritis).

• Independently manage the administrative, personnel, financial, and contracting functions for the GN trial group within the larger kidney disease renal research office.
• Oversee management of two clinical trial coordinators, including evaluations, troubleshooting, and advising, ensuring staff meet all requirements related to their assigned studies.
• Develop policies and procedures, as required.
• Maintain financial oversight of GN group research trials. Tasks include salary and expense allocations, invoicing, developing clinical trial budgets, negotiating contracts, and reconciling accounts.
• Maintain regulatory oversight in the startup, maintenance, and close-out of clinical research studies.
• Routinely interface with IRB, coordinators, investigators, sponsors, and monitors to ensure overall compliance with policies and procedures for conducting good clinical trials.

Hybrid - this role is eligible for a hybrid schedule of four to five (4-5) days per week on campus and as needed for in-person meetings.

Our dedicated research office faculty and staff make for a vibrant, supportive, and collaborative group to work with. Additionally, if you are someone who strives to grow and learn, you would be a proud part of the University of Colorado Anschutz Medical Campus, which is a world-class medical destination at the forefront of life-changing science, medicine, and healthcare.

We have AMAZING benefits and offer exceptional amounts of holiday, vacation, and sick leave! The University of Colorado offers an excellent benefits package, including:

• Medical:
  Multiple plan options
• Dental:
  Multiple plan options
• Additional Insurance:
  Disability, Life, Vision
• Retirement 401(a) Plan:
  Employer contributes 10% of your gross pay
• Paid Time Off:
  Accruals over the year
• Vacation Days: 22/year (maximum accrual 352 hours)
• Sick Days: 15/year (unlimited maximum accrual)
• Holiday Days: 15/year
• Tuition Benefit:
  Employees have access to this benefit on all CU campuses
• ECO Pass:
  Reduced-rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Minimum Qualifications:

• Bachelor's degree in any field.
• Four (4) years of clinical research or related experience.

Substitution: A combination of education and related technical/military/paraprofessional experience may be substituted for a bachelor's degree on a year-for-year basis.

Applicants must meet minimum qualifications at the time of hire.

• Bachelor's degree in science or health-related field.
• Five (5) years of clinical research or related experience.
• Prior experience providing program and/or project management duties in a clinical research setting.
• Experience with electronic data capture systems (e.g., EMR or EHR and data management systems).

• Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship or employment authorization for this position now or in the future.

• Strong project management skills and experience within a complex and diverse environment.
• Advanced knowledge and understanding of federal regulations and Good Clinical Practice (GCP).
• Demonstration of strong analytical and problem-solving skills.
• Demonstration of strong technological and Microsoft Suite…