Clinical Trial Manager - FSP

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.

Knowledge of site management and clinical monitoring procedures, including site qualification, initiation, monitoring, and closeout.

Experience with clinical data management processes and resolution of data queries.

Strong project management skills, with the ability to manage timelines, budgets, risks, dependencies, and competing priorities.

Strong problem-solving skills and the ability to identify and resolve trial issues efficiently.

Excellent communication skills, with the ability to clearly convey information, expectations, and decisions to cross-functional teams, investigators, vendors, and other stakeholders.

Strong organizational and time-management abilities in a complex, multi-stakeholder clinical environment.

Ability to work collaboratively while taking ownership of assigned studies and operational deliverables.

Commitment to maintaining compliance with applicable clinical research standards, processes, and regulatory requirements.

Willingness and ability to complete required training, maintain accurate documentation, and support operational reporting requirements.

Benefits

Full-time, remote position in Canada .

Opportunity to contribute to clinical research programs supporting the development of potential new therapies.

Exposure to diverse clinical operations, vendors, investigators, and cross-functional teams.

Opportunity to work within a collaborative, patient-focused clinical development environment.

Professional development through required and role-specific training.

Experience across clinical trial management, site operations, vendor oversight, regulatory compliance, and data management.

Opportunity to develop expertise across different clinical development programs and study phases.

Supportive environment focused on quality, collaboration, and continuous improvement.

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