Oncology Research Regulatory Manager

mcw; Milwaukee (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

MCW seeks a Regulatory Manager to lead the regulatory team of 2 supervisors and 17 staff, overseeing activation timelines, amendments, and quality assurance in clinical trial regulatory affairs.

The role involves representing the Regulatory Team in meetings, collaborating with investigators, sponsors, and other departments, and ensuring compliance with institutional and federal standards. Strong leadership, communication, and data-driven decision-making are essential.

Qualifications

• Minimum: Bachelor's degree; 6 years in research program coordination or regulatory.
• CCRC or CCRP certification required; CITI training within 90 days of hire.

Responsibilities

• Lead Regulatory Team in meetings with partners and internal process discussions.
• Advise investigators and staff on administrative and regulatory aspects of human subject research.
• Manage workload, performance, and training for the regulatory staff; develop standardized expectations.
• Collaborate on development of training materials and QA activities to ensure compliance.
• Maintain regulatory timelines and CTMS OnCore activity tracking.
• Coordinate with IRBs and other regulatory bodies as needed.
• Develop, implement, and monitor departmental policies and procedures for compliance.
• Act as liaison between department leadership and research staff.

Skills

Regulatory leadership

Regulatory compliance

Team management

Education

Bachelor's degree

CCRC or CCRP (preferred)

Tools

CTMS OnCore

eBridge

Florence

RightFax

IRB systems

Job description

MCW seeks a Regulatory Manager to lead the regulatory team of 2 supervisors and 17 staff, overseeing activation timelines, amendments, and quality assurance in clinical trial regulatory affairs.

The role involves representing the Regulatory Team in meetings, collaborating with investigators, sponsors, and other departments, and ensuring compliance with institutional and federal standards. Strong leadership, communication, and data-driven decision-making are essential.