Clinical Trials Manager
6 days ago
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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