Clinical Trial Manager
7 months ago
**Job Description for Clinical Trial Manager**
**Key Responsibilities**:
- Coordination of the overall conduct of a clinical trial, including assisting in development of the clinical trial protocol and managing the organization, development and/or submission of protocol amendments, case report forms, informed consent forms, study tools and templates, training materials, SOPs, and other study documents as required.
- Management of electronic documentation, such as eTMF (electronic Trial Master File) and EDCS (Electronic Data Capture System), and Database troubleshooting.
- Manage, coordinate, and submit the protocol and future amendments to the research ethics board (REB), including annual renewals, and safety reports.
- Assist in the negotiation of site contracts and site budgets, in accordance with sponsor requirements and budget framework.
- Prepare training material and presentations to be used for site initiation. ongoing training support and other educational requirements. Support and train participating site staff (QI, Co-I, coordinators, and assistants) involved in clinical activities and maintain documentation tracking site training.
- Oversee site preparedness of ethics submissions as well as support with REB queries and ICF modifications.
- Oversee site preparedness of Regulatory Inspections
- Organize and participate in Investigator, DSMB, Steering Committee and Coordinator Meetings, regular teleconferences with the team to ensure alignment on trial status, priorities, and upcoming milestones.
- Ensure the implementation and timelines of study deliverables are consistent with project requirements and budget expectations, including liaising with other service providers to ensure their deliverables are also being achieved.
- Assist with development of safety reporting plan and DSMB terms of reference.
- Oversee DSMB safety reporting and presentation of individual and aggregate data including preparation of safety reports, scheduling of the DSMB calls and meetings, liaising between DSMB and sites for data requests, controlling the flow of data across multiple groups while maintaining patient confidentiality and working within regulatory guidelines.
- Process invoices from clinical sites or contract service providers.
- Assist in the generation of study budget and enrolment forecasts.
- Oversee the management of Clinical Supplies for sites. Oversee all aspects of released study product including storage, delivery, use by the clinical site, and regulatory documentation.
**Salary**: $35.00-$75.00 per hour
Expected hours: 35 - 45 per week
Schedule:
- Monday to Friday
**Education**:
- Bachelor's Degree (preferred)
Work Location: Hybrid remote in Toronto, ON M5R 1A8
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