Clinical Operations Manager

Job Description

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:

• BSc (advanced degree such as MSc or PhD preferred) in a relevant scientific discipline.
• 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.
• Demonstrated expertise in clinical operations oversight, including vendor/CRO management and operational risk assessment.
• Strong understanding of GCP, ICH, and regional regulatory requirements.

Soft Skills:

• Enthusiasm for working within a small, fast-paced organization with lean infrastructure.
• Highly proactive, organized, and communicative, with a collaborative and solution-oriented mindset.
• Skilled at managing and influencing partners and CROs diplomatically to ensure proper oversight and accountability.
• Excellent written and verbal communication skills, with the ability to translate complex information across functional lines.
• Comfortable working independently on multiple competing priorities in a dynamic and evolving environment.