Manager, Clinical Trials

We are recruiting for a mission-driven Manager, Clinical Trials to join our team!

We're with you for life's journey. At Denver Health, purpose isn't just something we believe in-it's something we live every day, for life's journey.

Our Values

Respect | Belonging | Accountability | Transparency

Department

Research Operations

Job Summary

The Clinical Trials Manager oversees the DH Clinical Trials Services (CTS) team, which provides a centralized resource of comprehensive management services for DH investigators to conduct successful clinical trials in a methodologically sound, expedient and cost-effective manner. The mission of CTS is to provide centralized resources to the investigators to successfully conduct clinical trials in a methodologically sound, compliant, expedient and cost-effective manner. The conduct of clinical research has become increasingly complex due to multiple investigational drug combination treatments, their associated correlative studies, an increased number of targeted therapy trials and increasing regulatory oversight. CTS provides centralized management to bring the necessary expertise into progressively more specialized areas of clinical investigation.

Essential Functions:

• Develop, implement, and maintain centralized clinical trial SOPs (5%)
• Provide training of investigators and clinical trials staff in the development, conduct and analysis of clinical trials (5%)
• Ensure that trials are conducted in accordance with federal, state and institutional regulations, including billing compliance (5%)
• Facilitate all FDA regulatory audits (5%)
• Assist PIs with Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications when applicable (5%)
• Provide an essential layer of oversight and training for an increasingly large and complex clinical trials operation (5%)
• Oversee clinical trial portfolio management in conjunction with leadership to reflect the research goals, patient resource management and CTS resource allocation (10%)
• Supervise and train CTS staff to provide for the efficient and compliant conduct of clinical research trials (10%)
• Assisting leadership in aligning and developing CTS resources to match with department and institutional goals. Reports out analyses and KPIs to stakeholders. (5%)
• Conduct Medicare Cost Analysis Quality Assurance checks (5%)
• Directly supervise CTS staff (15%)
• Oversee the maintenance and any new implementations of Clinical Trials software systems, such as a Clinical Trials Management System (CTMS), Veeva SiteVault, and TriNetX (5%)
• Support new business opportunities by building relationships with clients to discuss service offerings. Contribute to initiatives to increase client base and diversify funding. (15%)
• Work closely with the Epic Research Analyst to develop and implement Epic Research advancements (5%)
• Other duties as assigned (0%)

Education:

• Bachelor's Degree Bachelor degree in related field or a combination of education and experience required. Required

Work Experience:

• 4-6 years Six years of research administration experience, with at least 3 years of clinical trial experience preferred. Required

Licenses:

Knowledge, Skills and Abilities:

• Proficiency with MS Office Suite.
• Knowledge of financial mechanism that relates to clinical trials.
• Collecting and analyzing complex data.
• Ability to prioritize and perform a variety of duties independently.
• Project management.
• Knowledge of Medicare Clinical Trial Policy (NCD 310.1). Knowledge Regulations overseeing Clinical Trials including - 21 CFR: parts 50, 312, and 812, 45 CFR Part 46, ICH GCP E6(R1)
• CCRA, CCRC, CCRP, or equivalent credential required.

Shift

Work Type

Regular

Salary

$101,200.00 - $161,800.00 / yr

Benefits

At Denver Health, we take care of the people who take care of our community. Our benefits are built to support your life, your family, and your future - with generous paid time off, fully paid parental leave, exceptional retirement contributions, comprehensive health coverage, and nationally recognized well-being programs. We invest in your growth through tuition assistance, career advancement pathways, and professional development - while also offering meaningful financial advantages through loan forgiveness eligibility and employer contributions. When you join Denver Health, you're joining a mission-driven organization that invests in you.

Here is a small list of our benefit programs:

• Paid time off starting at 28 days per year, inclusive of vacation, personal/sick, and 7 Holidays

• 100% paid parental leave up to 6 weeks

• Immediate eligibility for retirement plans with employer contribution up to 9.5%

• Generous medical, dental, vision plans in addition to employer paid disability and life insurance.

• Comprehensive well-being programs including on-site employee fitness center located on Denver Health main campus and nationally recognized RESTORE Center

• Free RTD EcoPass (public transportation)

• Childcare discount programs & exclusive perks on large brands, travel, and more

• Tuition reimbursement & assistance

• Education, coaching, and professional development opportunities through the Workforce Development Center (WFDC) that support internal career growth and advancement pathways

• Professional clinical advancement program & shared governance

• Public Service Loan Forgiveness (PSLF) eligible employer+ free student loan coaching and assistance navigating the PSLF program

• National Health Service Corps (NHCS) and Colorado Health Service Corps (CHSC) eligible employer

About Denver Health

Denver Health is an integrated, high-quality academic health care system considered a model for the nation that includes a Level I Trauma Center, a 555-bed acute care medical center, Denver's 911 emergency medical response system, 10 family health centers, 19 school-based health centers, Rocky Mountain Poison & Drug Safety, the Public Health Institute at Denver Health, Denver Health Medical Plan and Denver Health Foundation.

As Colorado's primary, and essential, safety-net health care system, Denver Health is a mission-driven organization that has provided millions in uncompensated care for the uninsured each year.

Located near downtown Denver, Denver Health is just minutes away from many of the cultural and recreational activities Denver has to offer.

Denver Health is an equal opportunity employer (EOE). We value the unique ideas, talents and contributions reflective of the needs of our community. All job applicants for safety-sensitive positions must pass a pre-employment drug test, once a conditional offer of employment has been made. Applicants will be considered until the position is filled.