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Denver Health · 8 hours ago

Manager, Clinical Trials

Denver, CO

Full-time

Onsite

Mid, Senior Level

$98K/yr - $153K/yr

4+ years exp

Denver Health is a mission-driven organization providing comprehensive healthcare services. They are seeking a Manager for Clinical Trials to oversee the Clinical Trials Services team, ensuring successful management of clinical trials in compliance with regulations and organizational goals.

Health CareHospitalMedical

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%)

Qualification

Clinical trial managementRegulatory complianceClinical Trials softwareProject managementFinancial mechanisms knowledgeData analysisMS Office SuiteMedicare Clinical Trial PolicyCCRACCRCCCRPSoft skills