Clinical Operations Manager

Job Description

<p><b>Job Title: Clinical Operations Lead</b></p><p><b>Location: 100% REMOTE </b></p><p><br></p><p><b>Client Business Driver</b></p><p>Our client is a small, emerging biopharmaceutical company that has acquired a small<b> </b>molecule<b> </b>asset<b> </b>administered<b> </b>via<b> </b>IV<b> </b>for the treatment of sickle cell disease. </p><p>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.</p><p><br></p><p><b>The Work</b></p><ul><li>The Clinical Operations Lead will oversee and manage all operational aspects of the Phase 3 program, ensuring timelines, quality, and compliance are maintained. </li><li>Responsibilities include, but are not limited to: Providing strategic and operational leadership through study startup and execution.</li><li>Managing external CRO and vendor relationships, ensuring clear communication, accountability, and adherence to timelines and deliverables.</li><li>Overseeing site selection, feasibility, and activation activities across participating regions.</li><li>Partnering closely with cross-functional teams (Regulatory, CMC, Data Management, and Safety) to ensure program readiness and alignment.</li><li>Supporting the development and review of study plans, protocols, monitoring tools, and essential documents.</li><li>Overseeing clinical supply management, including labeling, storage, and distribution to trial sites.</li><li>Making recommendations regarding potential bridging studies or protocol adaptations as needed.</li></ul><p><br></p><p><b>Hard Skills: </b></p><ul><li>BSc (advanced degree such as MSc or PhD preferred) in a relevant scientific discipline.</li><li>Proven success in a similar role within a small or emerging pharmaceutical company, ideally with hands-on experience in Phase 3 study startup and execution.</li><li>Demonstrated expertise in clinical operations oversight, including vendor/CRO management and operational risk assessment.</li><li>Strong understanding of GCP, ICH, and regional regulatory requirements.</li></ul><p><br></p><p><b>Soft Skills:</b></p><ul><li>Enthusiasm for working within a small, fast-paced organization with lean infrastructure.</li><li>Highly proactive, organized, and communicative, with a collaborative and solution-oriented mindset.</li><li>Skilled at managing and influencing partners and CROs diplomatically to ensure proper oversight and accountability.</li><li>Excellent written and verbal communication skills, with the ability to translate complex information across functional lines.</li><li>Comfortable working independently on multiple competing priorities in a dynamic and evolving environment.</li></ul>