Clinical Operations

• Lead operational planning and execution of Borealis’ clinical development programs from early development through later-stage studies
• Lead end-to-end operational planning and execution of the upcoming Phase 1/2 clinical trial
• Translate clinical development plans and protocols into operational strategies, timelines, budgets, enrollment projections, and risk mitigation plans
• Establish study governance, decision-making processes, and accountability across internal and external study teams
• Deliver studies on time and on budget in accordance with protocols, regulatory requirements, GCP, and Borealis quality standards
• Identify operational risks and lead mitigation and contingency planning
• Partner with Clinical Development, Regulatory, CMC, Data Management, Biostatistics, Translational Medicine, Quality, and other functions
• Own outsourcing strategy and lead CRO identification, competitive selection, RFPs, bid defenses, proposal assessment, contracting, governance, and performance oversight
• Establish and manage CRO and vendor expectations, responsibilities, escalation pathways, KPIs, timelines, quality standards, budgets, and deliverables
• Define vendor strategy for central laboratories, imaging providers, IRT, eCOA, clinical supply/logistics providers, specialty laboratories, and other study service providers
• Develop site identification, feasibility, selection, activation, patient recruitment, and retention strategies
• Monitor enrollment performance and develop mitigation plans
• Build investigator and site relationships and incorporate site needs into study planning and execution
• Design the Clinical Operations organization and develop resourcing strategies
• Recruit, onboard, develop, retain, coach, and mentor Clinical Operations professionals
• Report to the Senior Vice President, Translational Medicine

Head of Clinical Operations – Sr. Director / Executive Director

• Provide strategic oversight and daily delivery of medical and emergency response services
• Lead, coordinate, and manage medical services, equipment, facilities, and site staff
• Act as primary liaison between International SOS, the client, and site stakeholders
• Ensure contractual compliance, regulatory compliance, and alignment with company and client standards
• Manage subcontracted service provider performance and deliverables
• Prepare site reports and budgets
• Develop and implement multi-divisional training exercises
• Assist with staff planning, recruitment, performance assessment, and development
• Escalate issues that may jeopardize site/client relationships to the VP Operations
• Participate in daily, weekly, and monthly meetings with site teams, subcontractors, clients, and the Medical Services Centre
• Support Occupational Injury & Illness documentation and reporting
• Oversee staff roles, KPIs, safety requirements, induction, training, timesheets, rosters, payroll support, and performance management
• Serve as on-site contract lead and primary client contact
• Oversee patient records management and operational documentation
• Maintain inventories, stock control, accounting, and administrative records
• Apply the L3 Quality Management System and participate in audits, quality and safety calls, and continuous improvement
• Prepare and implement Plans of Action following audits, including closing P0 and P1 Hydra findings
• Manage client feedback and non-clinical incidents in Hydra
• Schedule maintenance of medical apparatus, equipment, and facilities
• Review variance reports, operational costs, and unexplained usage or cost increases
• Undertake project work and other reasonable duties requested by the VP Operations

Site Operations Manager

• Execute and oversee local operational clinical trial activities at the country level
• Own and oversee local regulatory and financial compliance
• Deliver country-specific trial commitments and objectives, especially during study start-up
• Influence investigators, vendors, external partners, and country managers to meet commitments
• Adhere to budget targets and payment timelines
• Address and resolve issues locally
• Maintain expertise in country-based regulations, laws, and procedures
• Support budget and contract negotiations
• Manage local ethics, legislation, regulatory environment, submission and approval processes
• Develop local-language informed consents and other site-ready and ongoing study deliverables
• Develop risk management and mitigation plans
• Assist with country and site budgets and deliver clinical and financial contracts
• Oversee and track clinical research-related payments and reconcile payments at study close-out
• Execute and oversee country submissions and approvals for assigned protocols
• Work with IRB/IEC and Regulatory Authorities on submission and approval interactions
• Manage country deliverables, timelines, and results for assigned protocols
• Contribute to local SOP development
• Collaborate with clinical operations, quality, finance, medical, regulatory, pharmacovigilance, compliance, legal, regional, vendor, site, IRB/IEC, and regulatory teams
• Align country timelines with Regional Operations and oversee local vendors
• Manage clinical and ancillary supplies, import/export requirements, supplies destruction, filing, archiving, retention, and insurance processes
• Enter and update country information in clinical, regulatory, safety, and finance systems
• Perform other assigned duties

Clinical Operations Manager

• Own end-to-end delivery of clinical programs across Sitero’s client portfolio
• Oversee CRAs, CTMs, and project management staff across Phase I–IV programs
• Ensure delivery against timelines, budgets, quality, and protocol adherence commitments
• Serve as executive sponsor and escalation point for complex, high-risk, or high-value studies
• Define and refine clinical operations SOPs, working practices, and quality standards
• Build resourcing models, capacity planning frameworks, and portfolio performance metrics
• Lead selection, implementation, and optimization of EDC, CTMS, eTMF, and risk-based monitoring systems
• Recruit, develop, and retain the clinical operations team
• Establish career pathways and competency frameworks for clinical operations
• Partner with Business Development on proposals, bid defense meetings, and scope development
• Serve as senior sponsor contact from kickoff through closeout
• Translate sponsor needs into realistic, risk-aware, adequately staffed operational plans
• Champion risk-based monitoring and quality by design
• Ensure inspection readiness and lead preparation for sponsor audits and regulatory inspections
• Monitor emerging FDA, EMA, and ICH E6 R3 guidance and ensure organizational alignment

Clinical Operations jobs in Canada

Head of Clinical Operations – Sr. Director / Executive Director

Site Operations Manager

Clinical Operations Manager

Senior Director, Clinical Operations