Job Summary:

The Clinical Trial Operations Manager is responsible for connecting science and operations to bring clinical studies to life through the execution of Phase I clinical trials. This position will be primarily responsible for leading efforts to operationalize regenerative, gene, and cellular therapy clinical trials while building and maintaining strong and impactful relationships and working cross-functionally and collaboratively to oversee trial operations.

Key Responsibilities:

• Manages the day-to-day operations and compliance of multiple highly complex Phase 1 clinical trials, across internal and external teams, from start-up to close-out.
• Develops a project plan for the study protocols to ensure the projected timelines, milestones, and budgets are met; provides senior leadership with metrics and updates as required.
• Leads core team meetings for assigned studies ensuring goals and deliverables are clearly dened, and issues, decisions, risks, and actions are appropriately tracked.
• Acts as an expert resource and the primary liaison between the site and internal/external stakeholders, to ensure timely study launch, administrative study maintenance, and closeout in accordance with local, state, and federal regulations, as well as contractual obligations.
• Works closely with leadership, internal constituents, ancillary committees, and external Sponsors to resolve barriers to trial activation and improve protocol activation timelines.
• Identifies, tracks and analyzes barriers in current clinical trials processes and recommends process improvements.
• Assists in the development of protocol-specific systems and documents including process flows, training manuals, Standard Operating Procedures (SOPs), and Case Report Forms (CRFs).
• Consults with investigators in developing submissions and responding to questions and requests for revisions from internal and external committees and boards (e.g., IRB).

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 1 day per week on campus and as needed for in-person meetings.

Why Join Us:

The opportunity offered by the Gates Institute is one of a kind. They blend the best of a large research organization of over 40,000 employees strong, with the family atmosphere of working with a team of 50+ highly dedicated people, operating on a top tier research campus - the University of Colorado - Anschutz Medical Campus.

The Gates Institute and its partners on the CU Anschutz Medical Campus are delivering lifesaving therapies and working to develop more every day. They are only limited by their resources and need you to make their journey a success!

In addition to the benefits offered, a few links are included below, identifying some of the exciting life sciences the Gates Institute is delivering to patients.

CU's Benefits: https://www.cu.edu/employee-services/benefits

The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off - vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness.

Diversity and Equity:

The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.

Qualifications:

Minimum Qualifications:

• A bachelor's degree in business, business administration, finance, accounting, education, social sciences, physical/biological sciences, engineering, healthcare administration, public administration, communications, information systems, or a directly related field from an accredited institution.
  • Substitution: College or university course work appropriate to the work assignment may substitute for the experience on a year-for-year basis.
• At least 4 years of professional level experience in clinical trial operations and/or management.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

• Master's degree in a related field from an accredited college or university.
• Experience with management and/or operations of clinical trials in the cellular and/or gene therapy space.
• Certified as a Clinical Research Professional (CCRP or equivalent).
• Experience submitting Investigational New Drug (IND) applications.
• Certified Associate in Project Management (CAPM), Project Management Professional (PMP) Certification, and/or project management experience in an academic environment.
• Professional clinical research experience in an academic medical center.

Competencies/Knowledge, Skills & Abilities:

• Strong critical thinking and problem-solving skills required.
• Exceptional communication and interpersonal skills, both oral and written.
• Excellent multi-tasking and organizational skills, as well as the ability to make complex decisions in a fast-paced environment.
• Ability to learn quickly and understand new technical concepts and processes.
• Flexible and able to adapt to program growth and evolving responsibilities.
• Self-motivated and able to work in a team environment.
• Able to work well under pressure, especially when assisting involved stakeholders.
• Proficiency in Microsoft Suite (especially Excel, PowerPoint, Word, and Project).
• A strong working knowledge of Good Clinical Practices (GCP), U.S. Food and Drug Administration (FDA) rules and regulations in relation to clinical trials, National Institutes of Health (NIH) guidelines, International Council for Harmonisation (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) regulations in relation to clinical trials, and other universally accepted practices and procedures within clinician trial management.

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: donna.3.parker@cuanschutz.edu

Screening of Applications Begins:

Immediately and continues June 30, 2024.

Anticipated Pay Range:

The starting salary range for this position has been established as $80,000 - $100,000.

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

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.