Description

You will lead and manage Oversight CRAs globally, ensuring high-quality monitoring and site management for clinical trials. You will build strong relationships with CRO partners and sites, contribute to process development, and implement risk-based monitoring strategies to help Apogee become a preferred sponsor.

Requirements

• Experience in clinical trial monitoring oversight management.
• Knowledge of GCP, regulatory requirements, and risk-based monitoring.
• Leadership and team management skills.
• Strong communication and issue resolution abilities.
• Ability to develop processes and training materials.

Responsibilities

• Lead and manage Oversight CRAs globally, ensuring study deliverables meet efficiency and quality.
• Hire, train, and develop in-house Oversight CRAs.
• Create, review, and revise departmental SOPs and policies.
• Contribute to development and implementation of risk-based monitoring strategies.
• Oversee site visit reports, metrics, and inspection readiness.