Performs protocol review and schedules kick-off meetings.
Liaises and assists with Data Management, Regulatory Services, CRA Services, Pharmaceutical Services, medical writing, medical monitors, and other departments as applicable during study set-up, project management and oversight, and project close-out.
Provides strategic leadership for ProSciento’s Quality department, establishing the vision, priorities, and organizational structure to support the company’s operations and business objectives.
Accountable for the design, implementation, maintenance, and continuous improvement of the Quality Management System (QMS), ensuring compliance with all applicable regulations including GCP, GLP, GMP (GxP), FDA, ISO, data privacy requirements, and other local, national, and international requirements.
