Clinical Operations Manager - new westminster

Job Title : Clinical Operations Lead

Location : 100% REMOTE

Client Business Driver

Our client is a small, emerging biopharmaceutical company that has acquired a small molecule asset administered via IV for the treatment of sickle cell disease.

Following Health Canada approval of their CTA submission, the organization is preparing to initiate its Phase 3 clinical program and requires an experienced Clinical Operations Lead to guide study startup and execution.

The Work

• The Clinical Operations Lead will oversee and manage all operational aspects of the Phase 3 program, ensuring timelines, quality, and compliance are maintained.
• Responsibilities include, but are not limited to : Providing strategic and operational leadership through study startup and execution.
• Managing external CRO and vendor relationships, ensuring clear communication, accountability, and adherence to timelines and deliverables.
• Overseeing site selection, feasibility, and activation activities across participating regions.
• Partnering closely with cross-functional teams (Regulatory, CMC, Data Management, and Safety) to ensure program readiness and alignment.
• Supporting the development and review of study plans, protocols, monitoring tools, and essential documents.
• Overseeing clinical supply management, including labeling, storage, and distribution to trial sites.
• Making recommendations regarding potential bridging studies or protocol adaptations as needed.

Hard Skills :

Soft Skills :