Regulatory Program Lead, Clinical Research

Medical College of Wisconsin; Wauwatosa (WI); Sur place; USD 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

Healthcare coverage

403B retirement package

Vacation and paid holidays

Tuition reimbursement

Parental leave

EFAP

Résumé du poste

Medical College of Wisconsin seeks a Regulatory Manager to lead a team of 2 regulatory supervisors and 17 staff. You will monitor performance, drive process improvements, and ensure regulatory compliance across trials.

You will coordinate with principal investigators, sponsors, and cross-department teams, guiding regulatory activities from pre-trial to ongoing trial maintenance and reporting to stakeholders.

Qualifications

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

Responsabilités

• Lead the Regulatory Team and represent it in meetings with partner organizations and internal discussions.
• Advise investigators and staff on regulatory aspects of human subject research and trial maintenance.
• Oversee time, workload and performance management for the regulatory team.
• Recruit and train clinical research staff; develop standardized expectations and monitor performance.
• Maintain CTMS (OnCore) timelines and collect, analyze, and report program data.

Connaissances

Regulatory knowledge

Clinical research coordination

Leadership

Communication skills

Project management

Formation

Bachelor's degree

Outils

OnCore CTMS

eBridge

IRB systems

Description du poste

Medical College of Wisconsin seeks a Regulatory Manager to lead a team of 2 regulatory supervisors and 17 staff. You will monitor performance, drive process improvements, and ensure regulatory compliance across trials.

You will coordinate with principal investigators, sponsors, and cross-department teams, guiding regulatory activities from pre-trial to ongoing trial maintenance and reporting to stakeholders.