Associate Director, Monitoring Oversight Management

Apogee Therapeutics is seeking an Associate Director, Monitoring Oversight Management, to manage Apogee's Oversight CRAs who will oversee the performance of CRO monitoring and site management related activities for Apogee sponsored clinical trials.

Requirements

• Leadership of Oversight CRAs globally
• Hiring of in-house Oversight CRAs
• Creation, review, and revision of departmental SOPs and policies
• Conducting regular meetings with Oversight CRA team and individual CRAs
• Creation of SOPs and processes to support monitoring excellence organization
• Training and development of in-house Oversight CRAs
• Contribution to development and implementation of risk-based monitoring strategies
• Assistance with resourcing/capacity management projections
• Facilitation of resolution of region-specific and site management related challenges
• Communication and issue resolution with clinical vendors
• Creation and implementation of monitoring processes, tools, and documents
• Periodic review of monitoring visit reports and metrics
• Compilation and provision of clinical monitoring metrics
• Support and liaison with clinical site personnel
• Review and approval of time sheets and expense reports
• Conducting periodic quality visits for Senior Oversight CRAs

Benefits

• Market competitive compensation and benefits package
• Performance bonus
• Equity grant opportunities
• Health, welfare & retirement benefits
• Competitive time off, including three weeks PTO and two one-week company-wide shutdowns a year
• Dedicated paid sick leave