Regulatory Research Manager — Clinical Trials Lead

Medical College of Wisconsin; Milwaukee (WI); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Health insurance

403B retirement package

Paid time off

Tuition reimbursement

Parental leave

EFAP

Pet insurance

Job summary

The Medical College of Wisconsin is seeking a Regulatory Manager to lead a regulatory team of 2 supervisors and 17 staff. You will monitor performance, drive improvements in activation timelines, and ensure compliance across clinical trials.

You will collaborate with investigators, sponsors, and other departments to maintain high-quality regulatory operations. Responsibilities include mentoring staff, coordinating CTMS OnCore and supporting systems, and developing policies to meet state and

Qualifications

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

Responsibilities

• Lead Regulatory Team; represent team in meetings with partners and internal discussions.
• Advise investigators on administrative and regulatory aspects of human subject research.
• Manage time, workload, and performance for the regulatory team.
• Recruit, train, and assess staff; develop standardized expectations and training materials.
• Maintain protocol activation timelines; utilize CTMS OnCore and assist with regulatory requirements.
• Coordinate with IRBs, Florence, RightFax, eBridge and data systems as needed.
• Develop and enforce departmental policies and SOPs; ensure compliance with standards.
• Identify system obstacles and communicate with investigators; liaison with leadership and external agencies.
• Develop, implement, and monitor QI activities and data quality controls.

Skills

Leadership

Staff Oversight

Regulatory Knowledge

Communication

Project Management

Quality Assurance

Education

Bachelor's degree

Tools

OnCore

eBridge

Florence

RightFax

Job description

The Medical College of Wisconsin is seeking a Regulatory Manager to lead a regulatory team of 2 supervisors and 17 staff. You will monitor performance, drive improvements in activation timelines, and ensure compliance across clinical trials.

You will collaborate with investigators, sponsors, and other departments to maintain high-quality regulatory operations. Responsibilities include mentoring staff, coordinating CTMS OnCore and supporting systems, and developing policies to meet state and