Manager, Clinical Trials

We are here for lifes journey.
Where is your life journey taking you

Being the heartbeat of Denver means our heart reflects something bigger than ourselves something that connects us all:

Humanity in action Triumph in hardship Transformation in health.

Department

• 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%)

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

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

• 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

Salary

Benefits

• Outstanding benefits including up to 27 paid days off per year immediate retirement plan employer contribution up to 9.5% and generous medical plans

• Free RTD EcoPass (public transportation)

• On-site employee fitness center and wellness classes

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

• Tuition reimbursement & assistance

• Education & development opportunities including career pathways and coaching

• 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

Our Values

• Respect

• Belonging

• Accountability

• Transparency

All job applicants for safety-sensitive positions must pass a pre-employment drug test once a conditional offer of employment has been made.

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 Denvers 911 emergency medical response system 10 family health centers 19 school-based health centers Rocky Mountain Poison & Drug Safety a Public Health Institute an HMO and The Denver Health Foundation.

As Colorados primary and essential safety-net institution Denver Health is a mission-driven organization that has provided billions in uncompensated care for the uninsured. Denver Health is viewed as an Anchor Institution for the community focusing on hiring and purchasing locally as applicable serving as a pillar for community needs and caring for more than 185000 individuals and 67000 children a 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.

Applicants will be considered until the position is filled.