Manager, Clinical Trials

Denver Health and Hospital Authority • Denver, CO

1d • Onsite

About The Position

We are recruiting for a motivated Manager, Clinical Trials to join our team! We are here for life’s 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 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.

Requirements

• Bachelor's Degree Bachelor degree in related field or a combination of education and experience required.
• 4-6 years Six years of research administration experience, with at least 3 years of clinical trial experience preferred.
• 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)
• All job applicants for safety-sensitive positions must pass a pre-employment drug test, once a conditional offer of employment has been made.

Nice To Haves

• CCRA, CCRC, CCRP, or equivalent credential required.
• Proficiency with MS Office Suite.

Responsibilities

• 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%)

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees