• Central contact for the clinical operations team for designated project communications, correspondence, and associated documentation.
• Set up and maintain study-specific paper and electronic TMFs.
• Perform and oversee Quality Control (QC) reviews of essential study documents and TMF to ensure ongoing inspection readiness and compliance with applicable regulations and Good Clinical Practices.
• Track and report CRO’s ability to maintain TMF health metrics on an ongoing basis.
• Process essential documents and ensure they are correctly filed in the appropriate TMF.
• Track and report study CRO metrics; inclusive of start-up, data management, and contracting as needed.
• Participate in GxP audits and related clinical operations compliance and inspection readiness activities.
• Prepare and track study documents (e.g., contracts, budgets, IRB documentation).
• Assist with information gathering, literature searches, and creation of presentations, as needed.
• Maintain and oversee tasks performed by CRO related to databases/spreadsheets, as necessary, to facilitate tracking/documentation of departmental activities (e.g., CRFs, queries, clinical data or sample flow, etc.)
• Administer user access and change control within Anavex’s electronic systems.
• Assist in User Acceptance Testing (UAT) for all Electronic Data Capture (EDC) needs in regard to Data Management and all Clinical Systems.
• Assist in ensuring all Systems, including but not limited to, EDC (Data Management), TMF, CTMS, Payments, etc. are best utilized per Quality standards.
• Assist with vendor management and associated logistics, as assigned.
• Contribute to the creation of presentations, as needed for project, departmental, sponsor, and/or business development presentations.
• Collaborate with Associate Director, Clinical Operations, Clinical Supply Unit, and QA in order to manage activities related to Clinical Supplies.
• Manage study-related payment procedures. Interact with external providers during study conduct (CROs, monitors, and, occasionally, investigators and Hospital personnel)
• Provide input for budget development and check monthly costs invoiced based on planned study activities vs actual.
• Participate in the completion and review of Request for Proposals (RFPs) in collaboration with the Clinical Operations Management.
• Organize and/or participate in meetings with CROs. Ensure appropriate meeting minutes are prepared and filed in TMF.
• Assist CRAs with the preparation, handling, and distribution of Clinical Trial Supplies and maintenance of tracking information.
• Assist in creating and implementing departmental SOPs and procedures.

The position will be filled at a level commensurate with experience.