Lead Regulatory Manager, Cancer Center Trials

Milwaukee Succeeds; Milwaukee (WI); Hybrid; USD 95,000 - 140,000; Full time

Benefits offered by this job

Health insurance

Tuition Reimbursement

Paid Parental Leave

EFAP

On campus fitness facility

Job summary

Medical College of Wisconsin in Milwaukee is seeking a Manager Research Regulatory for the Cancer Center to lead the regulatory team of 2 supervisors and 17 staff. You will oversee activation/amendment timelines, quality of work, and staff performance, setting tone for ownership, urgency, and accountability.

Responsibilities include coordinating CTMS OnCore, IRB/IND processes, data reporting, training, and cross‑department collaboration; develop policies, monitor program data, and ensure

Qualifications

• Minimum 6 years in research program coordination or regulatory work.
• Experience in clinical trials regulatory activities and staff oversight.
• Certification in regulatory science is preferred.

Responsibilities

• Lead regulatory team at meetings with partners and internal discussions.
• Guide investigators on administrative/regulatory aspects of human research.
• Manage time, workload and performance for the regulatory staff.
• Recruit/train staff and develop standardized expectations.
• Maintain protocol activation timelines and use CTMS OnCore for tracking.
• Oversee data systems (Florence, RightFax, eBridge) supporting research.
• Develop departmental policies to ensure SOP and federal standard compliance.
• Coordinate annual regulatory education and outreach activities.

Skills

Regulatory knowledge

Leadership

Staff oversight

CTMS OnCore

IND/IRB knowledge

Education

Bachelor's degree

CCRC/CCRP certification

Tools

e-Bridge

IRB systems

CT.gov

CTMS OnCore

Florence

RightFax

eBridge

Job description

Medical College of Wisconsin in Milwaukee is seeking a Manager Research Regulatory for the Cancer Center to lead the regulatory team of 2 supervisors and 17 staff. You will oversee activation/amendment timelines, quality of work, and staff performance, setting tone for ownership, urgency, and accountability.

Responsibilities include coordinating CTMS OnCore, IRB/IND processes, data reporting, training, and cross‑department collaboration; develop policies, monitor program data, and ensure