The Clinical Trial Manager will support the Company's clinical trial activities, managing day-to-day operations of one or more phase 1-3 clinical trials, including trial start up, conduct, and close out activities.
Requirements
- Serve as the primary contact for managing protocol execution, including oversight of the CRO, other study service providers, and consultants
- Lead cross-functional study execution team in support of study deliverables
- Support establishment of study milestones and ensure accurate tracking and reporting of study metrics and timelines to leadership
- Ensure clinical trials are managed and executed in accordance with ICH GCP, regulations, the protocol, and company-specific SOPs
- Assist in preparation and review of clinical trial documentation such as protocol, informed consent, Investigator Brochure, Clinical Monitoring Plan, Project Plan, Case Report Forms, Statistical Analysis Plan, Clinical Study Reports, and other study level documents
- Ensure that the Trial Master File (TMF) is set up and maintained appropriately throughout the trial, including periodic reviews
- Participate and coordinate resolution of audit finding and ensures audit-ready condition of clinical trial documentation including central clinical files
- Participates in service provider selection process as a part of outsourcing activities
- Proactively identifies, with the support and guidance from Senior Clinical Operations staff, and supports development of plans and resolution of project issues and participates in process improvement initiatives as required
- Supports assessing operational feasibility, recommending study execution plan and site selection under the Director of Clinical Operations
- Responsible for the selection and study specific training of CRO study staff, monitors, investigational sites, and service providers
- In conjunction with legal group, facilitate the development of clinical trial agreements and other relevant documents
- Manage clinical trial budgets, providing ongoing financial reporting and projections
- Negotiate and finalize site contracts and budgets
- Perform and manage data review process on an ongoing basis
- Perform site visits including site qualification, initiation, monitoring and close-out visits, as needed
- Oversee outsourced monitoring by reviewing, monitoring reports to ensure quality and resolution of site-related issues
- Ensures tracking and review of protocol deviations and assesses impact on study data
- Develops and manages study budget and maintain within financial goals; Reviews and approves clinical invoices against approved budget
- Provides oversight for forecasting of clinical supplies, including study drug and supplies
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
