Clinical Trials Manager

6 days ago

Melbourne, Victoria, Australia Allucent Full time
Job Title: Clinical Trials Manager

We are seeking a highly skilled Clinical Trials Manager to join our team at Allucent. As a Clinical Trials Manager, you will be responsible for providing leadership and management to the Clinical Research Associates (CRAs) and other clinical functional groups in their day-to-day clinical trial activities.

Key Responsibilities:

  • Manage the study start-up process in collaboration with the Project Manager, Regulatory Lead, and Global Site Activation Manager.
  • Coordinate and oversee critical documentation collection, maintenance, and filing.
  • Prepare monitoring plans, provide input to TMF plans, and ensure all plans are implemented.
  • Contribute to the development of CRF guidelines and edit checks.
  • Customize site visit report checklists and templates according to study-specific requirements.
  • Develop or modify templates for monitoring activities according to study requirements.
  • Select investigators and sites, review and approve SEV reports.
  • Manage site initiation, review and approve SIV reports.
  • Review, manage, resolve, and escalate monitoring visit reports.
  • Ensure successful trial close-out, identify critical activities for timely and efficient close-out.
  • Responsible for timelines, budget, and quality of Clinical Monitoring team deliverables, identify risks and issues, and escalate to the Project Manager, Line Manager, and CRMs/COMs.
  • Coordinate and manage site visit schedules.
  • Manage CRA site assignments and schedules.
  • Develop patient recruitment and retention plans.
  • Provide information and input about planned activities to the Project Manager for regular Project Review Meetings and attend Project Review Meetings if needed.
  • Conduct project co-monitoring (if required) and team training.
  • Site contact for protocol clarifications and subject enrollment if CRA unavailable.
  • Monitor and manage trial materials supplies, ensure Investigational Product and other study supplies are shipped to sites.
  • Review data listings and query reports to identify trends and ensure proactive re-training is conducted with CRAs and site staff.
  • Oversee the process of protocol deviation documentation, tracking, and escalation.
  • Participate in the development of study newsletters communication.
  • Relay project status and issues to the Project Manager.
  • Request through the Project Manager appropriate Clinical Operations staffing, workload, and resources and report study deliverables and resource needs.
  • Assist, where appropriate, the Project Manager in discussions with clients on study documentation issues or technical-related documentation concerns that may arise.
  • Review study systems (CTMS, CRF, IRS, central lab portal, etc.) updates on a regular basis, ensure systems reports are up to date, and reports generated are current and correct.
  • Coach/mentor CRA team.
  • Develop and deliver project-specific training and provide input to Project Specific Training Matrix.
  • Ensure project consistency within and across projects by following SOPs.
  • Assist and support in the preparation of study-specific training matrix and various training material (including SOPs training, as well as specific-therapeutic area-related). Assist and support web-based training material preparation. Assist when needed in the preparation of company and scientific/medical presentations to potential clients and at Investigators' meetings and other committees' meetings as requested.
  • Assist in revision of Site Budgets and manage Investigator and Site Payments.
  • Contribute to case management and timely closure.
  • Support the Project Manager in the management of study vendors as required.
  • Provide input into proposals when required.
  • Actively participate in preparation, attendance, and presentation of bid defense or any other study-related meetings.

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