Clinical Research Program Manager

Location: 1860 Shawano Ave, Green Bay, Wisconsin, United States

This position works 40 hours per week and is benefit eligible.

About the role

The Clinical Research Program Manager leads the day-to-day operations and strategic direction of the Clinical Research Program and provides direct supervision to clinical research staff (up to three direct reports). Under the direction of the Executive Director, the Manager coordinates and oversees research study-specific clinical and regulatory activities across multiple study protocols of different therapeutic areas and phases, in accordance with applicable GCP/ICH regulations, Standard Operating Procedures (SOPs), and study-specific protocols and processes.

The Manager oversees the conduct of clinical research trials—including patient identification and eligibility, the informed consent process, case report form documentation, and the identification and reporting of adverse events to the FDA, IRB, and/or study sponsor as applicable—and ensures the site and principal investigators remain compliant with approved protocols. The Manager serves as the primary point of contact for research-related questions and activities, acts as a liaison among patients, families, healthcare professionals, and sponsors, sets program priorities, and drives the quality, growth, and sustainability of clinical research at Prevea Health.

Responsibilities

• Leads and directs the day-to-day operations and strategic direction of the Clinical Research Program—including goal setting, operational priorities, and business development—and serves as the primary point of contact and subject matter resource for all clinical research activities at Prevea Health, in collaboration with internal departments and external partners, including HSHS.
• Negotiates research study budgets in partnership with sponsors, investigators, and internal stakeholders, and oversees related financial processes, including budget reconciliation, payment collection, and tracking.
• Ensures regulatory compliance by collaborating with the HSHS Institutional Review Board (IRB) and other external IRBs, and by developing, implementing, and maintaining research Standard Operating Procedures (SOPs) and ensuring staff adherence.
• Oversees the conduct of clinical research trials, including patient identification and eligibility, the informed consent process, case report form documentation, and the identification and reporting of adverse events to the FDA, IRB, and/or study sponsor as applicable.
• Acts as a liaison among patients, families, healthcare professionals, and sponsors.
• Sets program priorities and drives the quality, growth, and sustainability of clinical research at Prevea Health.