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. Authorizes release of Investigational Product Coordinates site contracts and budgets negotiation and participates in the management of investigator payments Manages project milestones (for clinical deliverables) and proactively addresses deficiencies: Holds study team members accountable to the study timelines and Time Entry Guidelines Provides input to the PM in preparation for Monthly Project Reviews Attends and provides information at Client teleconferences/study team