Sitero provides technology-enabled clinical trial solutions for healthcare and life sciences organizations. Its services support research operations across site activation and support, clinical data management, biostatistics, drug safety, pharmacovigilance, and ethical review.
The company also delivers eClinical systems for key trial workflows, including electronic data capture, randomization and trial supply management, clinical trial management, electronic consent, and payments. Additional offerings include biosafety consulting and related compliance support, helping clinical research organizations manage studies with integrated operational, technology, and safety services.
Senior Director of Clinical Operations - Hybrid Mississauga
Lead Phase I–IV clinical trial delivery at Sitero, a life sciences CRO. Build scalable operations, teams, systems, and quality processes across the client portfolio.
Description
- Direct end-to-end delivery of clinical programs across Sitero’s client portfolio
- Manage CRAs, CTMs, and project managers across Phase I–IV studies
- Hold programs accountable for timelines, budgets, quality, and protocol compliance
- Act as executive sponsor and escalation lead for complex, high-risk, and high-value studies
- Develop and continuously improve clinical operations SOPs, practices, and quality standards
- Create resourcing models, capacity plans, and portfolio performance measures
- Lead the selection, rollout, and optimization of EDC, CTMS, eTMF, and risk-based monitoring systems
- Recruit, develop, and retain clinical operations professionals
- Create career paths and competency frameworks for the clinical operations function
- Collaborate with Business Development on proposals, bid defenses, and scope definition
- Serve as the senior sponsor contact from study initiation through closeout
- Convert sponsor objectives into practical, risk-conscious, appropriately staffed operating plans
- Promote risk-based monitoring and quality-by-design principles
- Maintain inspection readiness and lead preparation for sponsor audits and regulatory inspections
- Track evolving FDA, EMA, and ICH E6 R3 guidance and align organizational practices accordingly
Requirements
- Bring at least 12 years of clinical research experience
- Have 5 or more years of leadership experience in a CRO or full-service sponsor organization
- Demonstrate broad expertise across Phase I–IV trials and therapeutic areas
- Experience working with complex or underserved populations is advantageous
- Show a record of building and scaling clinical operations functions
- Demonstrate successful delivery of multi-study portfolios on schedule and within budget while preserving quality
- Apply risk-based monitoring principles and modern clinical trial technology platforms effectively
- Bring commercial judgment and confidence in business development, client discussions, and budget negotiations
- Communicate exceptionally well with scientific, operational, and executive stakeholders
- Be willing to work shifts when required
Benefits
- Competitive compensation
- Paid leave
- Healthcare coverage
- Retirement benefits
- Hybrid schedule with three days per week in the Mississauga office and two days working from home
- Standard Monday-to-Friday, 40-hour workweek