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Biotech
Leads clinical research and evidence development projects globally, overseeing project planning, delivery, budgets, risks, quality, regulatory compliance, reporting, vendors, and client relationships. Directs Project Managers and cross-functional teams, manages departmental resources and process improvements, supports business development, and supervises project management staff. Ensures adherence to ICH-GCP, FDA and EMA requirements, EU Clinical Trials Directives, GDPR, HIPAA, timelines, financial targets, and contracted quality standards.
Biotech
Leads global clinical and evidence development projects within a CRO, overseeing project planning, delivery, budgets, risks, quality, regulatory compliance, vendors, and client relationships. Manages Project Managers and cross-functional teams, supports business development, develops operational strategies and SOPs, allocates resources, and drives process improvements. Responsibilities include oversight of multiple projects and programs, financial performance, reporting, staff development, and adherence to ICH-GCP, FDA, EMA, GDPR, HIPAA, and other applicable regulations.
Biotech
Leads and develops a team of 10–15 Clinical Project Managers supporting clinical studies, PASS, registries, and real-world evidence programs. Owns resource allocation, utilization, contingency planning, operational KPIs, SOP compliance, inspection readiness, quality actions, financial performance, and client delivery. Partners with cross-functional, HR, Finance, and global leadership teams on staffing, organizational planning, performance management, and portfolio execution.
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