Clinical Sciences Program Manager

Job Summary:

The Anschutz Health and Wellness Center seeks an Assistant Director of Clinical Trials to work on various industry-sponsored trials of investigational weight loss medications. This position will afford the opportunity to manage trials from start to finish, assisting with financial and regulatory management and overseeing day-to-day operations of the clinical trials team. This role provides the opportunity to lead a research team in the exciting and expanding arena of antiobesity medications.

Key Responsibilities:

25% Financial Oversight

• Create and negotiate study budgets and oversee contract execution, amendments and extensions for each study
• Reconcile study payments, forecast spending on each study, regularly review study spending to ensure each trial stays within budget
• Track invoiceable items and assist with invoicing sponsors and provide payment for study invoices

25% Regulatory Oversight

• Develop, review, and maintain regulatory documentation for each trial (maintain Investigator Site Files for multiple studies)
• Responsible for IRB submissions and approvals throughout each trial to various IRBs
• Ensure program/project compliance with Food and Drug Administration (FDA), sponsor and site guidelines and regulations

50% Management and Coordination

• Develop and oversee long term goals for clinical trials at AHWC in coordination with study PIs
• Assist with and oversee the day-to-day operations of clinical trials; oversee work of study coordinators, trouble shoot issues with participants and study visits, seek PI and/or sponsor guidance as needed
• Responsible for scheduling monitoring visits and regular communications with sponsors as needed
• Oversee retention and recruitment for trials with a goal of recruiting diverse populations for participation in trials.
• May perform supervision and management responsibilities for a team of 2 or more professionals.

Sponsorship Statement: We are unable to sponsor applicants for work visas for this position.

Work Location:

Onsite - This role is expected to work onsite and is located in Aurora, CO, with the possibility of 1 virtual day per week, as the schedule allows.

Why Join Us:

The CU Anschutz Health and Wellness Center (CU AHWC) resides within the School of Medicine at the University of Colorado Anschutz Medical Campus. The CU AHWC is an interdisciplinary center where top researchers work side-by-side with clinicians to develop and deliver wellness and weight loss programs. The Anschutz Health and Wellness Center houses a fitness center and a multidisciplinary weight loss and wellness clinic (where research visits occur). All the space, tools, and people needed to successfully execute weight loss clinical trials exist under the CU AHWC roof.

Why work for the University?

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: 10/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.

Qualifications:

Minimum Qualifications:

• Bachelor's degree in any field
  
  
  
  • A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year-for-year basis
  
  
  
  
• Four (4) years of clinical trial experience

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Bachelor's degree in science or health health-related field
• Five (5) years non-industry clinical trial experience or 4 years of industry clinical trial experience
• Prior experience providing research management in a clinical research setting
• Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
• Experience with using External IRBs.

Knowledge, Skills and Abilities:

• 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
• Strong attention to details
• Ability to communicate effectively, both in writing and orally
• Ability to establish and maintain effective working relationships with employees at all levels throughout the institution
• Outstanding customer service skills
• Knowledge of basic human anatomy, physiology, and medical and medication terminology
• Ability to interpret and master complex research protocol information

How to Apply:

For full consideration, please submit the following document(s):

1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position
2. Curriculum vitae / Resume
3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address

Questions should be directed to: Jenna Stanford, jenna.stanford@cuanschutz.edu

Screening of Applications Begins:

Screening begins immediately and continues until finalists are identified; however, preference may be considered for those who apply before May 2nd, 2025.

Anticipated Pay Range:

The starting salary range for this position has been established as:

$68,394 - $86,998

The above salary range (or hiring range) represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level.

Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Total Compensation Calculator: http://www.cu.edu/node/153125

Equal Employment Opportunity Statement:

The University of Colorado (CU) is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing non-discrimination in employment. We are committed to creating a workplace where all individuals are treated with respect and dignity, and we encourage individuals from all backgrounds to apply.

ADA Statement:

The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@cuanschutz.edu.

Background Check Statement:

The University of Colorado Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program.