Clinical Trial Manager - Australia

The Clinical Trial Manager (CTM) is responsible for the management and oversight of assigned duties and clinical deliverables on studies. Such duties may include developing project documents and deliverables; effectively communicating with the Project Manager (PM), Client and study team; managing and training CRAs and other study team members; administering and providing oversight of vendor and/or study budgets and time entry; ensuring that clinical metrics are met, and operational risks identified and mitigated and managing third-party clinical vendors and contract staff.

Duties and Responsibilities

Develops the Site Activation Plan and customizes study start-up documents as needed Coordinates site identification, selection and recruitment Oversees initial regulatory document collection and review Oversees regulatory and ethics submission processes Preparation and/or review of essential study documents, e.g. Monitoring Guidelines, CRF Completion Guidelines, Patient Information and Informed Consent Form, etc.