Clinical Trial Manager - FSP

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Clinical Trial Manager - FSP based in Canada. As a Clinical Trial Manager, you will oversee the delivery of clinical trials from initiation through closeout, helping ensure studies remain on schedule, within budget, and aligned with quality standards. You will work closely with clinical operations teams, investigators, CRAs, vendors, CROs, and other stakeholders throughout the study lifecycle. The role combines strategic planning, operational oversight, vendor management, regulatory compliance, and hands-on trial execution. You will contribute to study documentation, monitoring activities, site management, enrollment tracking, data processes, and investigator engagement. Your work will help maintain study integrity and ensure clinical trials are conducted in accordance with GCP, protocols, SOPs, and applicable regulations. This is an opportunity to join a collaborative clinical development environment where strong project management and problem-solving skills directly support the advancement of potential therapies. The position is remote in Canada and offers exposure to complex, cross-functional clinical research programs. Accountabilities - Manage individual clinical trials and/or programs as part of a broader Clinical Trial Working Group, overseeing activities from study initiation through closeout. - Manage external vendors and contract research organizations to support efficient, high-quality trial execution. - Prepare and maintain key study documents, including Monitoring Manuals, Study Operations Manuals, Source Data Verification Plans, and Laboratory Manuals. - Coordinate the design and review of study materials such as case report forms, patient diaries, participation cards, and source documents. - Support protocol development and contribute to the completion of clinical study reports. - Plan and oversee monitoring activities, including routine on-site monitoring where required, to ensure adherence to GCP, SOPs, and study protocols. - Provide guidance, direction, and operational management to Clinical Research Associates.

- Track patient enrollment and coordinate site qualification, initiation, monitoring, and closeout activities. - Review site reports and support coordination of clinical data management activities and data query resolution. - Coordinate study supplies and oversee related operational requirements. - Support negotiation and management of contracts with clinical trial service vendors. - Review informed consent forms, CRFs, protocols, and other study-related materials. - Plan and participate in investigator meetings and maintain effective communication with investigators and study stakeholders. - Ensure investigational sites remain compliant with applicable SOPs, ICH-GCP principles, and relevant regulatory requirements. - Maintain an accurate and up-to-date Trial Master File throughout the study lifecycle. - Identify, investigate, and resolve operational issues promptly to minimize delays and protect study quality and integrity. - Manage multiple priorities, deadlines, and stakeholders while maintaining effective cross-functional collaboration. Requirements - Degree in a life sciences field or a related discipline is preferred. - Strong knowledge of Good Clinical Practice (GCP) and clinical research regulatory requirements, including applicable ICH and FDA guidelines. - Experience managing clinical trials and/or clinical trial operations from initiation through closeout. - Practical experience with clinical trial documentation and processes, including protocols, CRFs, monitoring plans, informed consent documentation, and study manuals. - Experience managing or working with CROs, external vendors, clinical sites, and other clinical research partners.