27 Sep
|
Sitero
|
Ontario
Sitero is an emerging leader in Clinical services and software solutions for the life sciences industry. We have experience and expertise in a diverse range of therapeutic areas and focus on innovative, technology-enabled solutions that allow our clients to focus on their core strengths. For early phase studies through Phase III clinical trials, our experienced team delivers high-touch services and technology to ensure the safety of all stakeholders across the clinical research community with an emphasis on ethics, compliance, and innovation.
Job Title: Senior Director, Clinical Operations
Location: Mississauga, Canada (Hybrid; 3X per week in office)
Function: Clinical Operations
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Program Delivery
Accountable for the clinical execution of all full-service programs across phases I-IV, including oversight of CRAs, CTMs, and project management staff
Ensure delivery against timeline, budget, quality, and protocol adherence commitments across the portfolio
Serve as executive sponsor and escalation point for complex, high-risk, or high-value studies
Operational Infrastructure
Define and continuously refine Sitero's clinical operations SOPs, working practices, and quality standards
Build and maintain resourcing models, capacity planning frameworks, and performance metrics that give leadership real-time visibility into portfolio health
Lead the selection, implementation, and optimization of clinical systems (EDC, CTMS, eTMF, risk-based monitoring tools)
People Leadership
Recruit, develop,
and retain a high-performing clinical operations team - CRAs, CTMs, Sr. and Project Directors
Build a culture of accountability, scientific curiosity, and client partnership
Establish clear career pathways and competency frameworks for the clin ops function
Client & Business Partnership
Partner with Business Development on proposals, bid defense meetings, and scope development - functioning as the clinical operations voice in business acquisition
Serve as a trusted senior contact for sponsor clients throughout engagement, from kickoff through closeout
Translate sponsor needs into operational plans that are realistic, risk-aware, and staffed to deliver
Quality & Compliance
Champion a risk-based monitoring philosophy and embed quality by design into every program
Ensure inspection readiness across all active studies; lead preparation for sponsor audits and regulatory inspections
Monitor and respond to emerging regulatory guidance (FDA, EMA, ICH E6 R3) and ensure organizational alignment
EDUCATION AND EXPERIENCE REQUIRED:
12+ years of clinical research experience, with at least 5 in a leadership role within a CRO or full-service sponsor environment
Deep expertise across trial phases (I-IV)
and therapeutic areas; experience in complex or underserved populations is a plus
Demonstrated ability to build and scale clinical operations functions - not just manage existing ones
Track record of delivering multi-study portfolios on time and within budget while maintaining quality
Fluency in risk-based monitoring principles and modern clinical trial technology platforms
Strong commercial instincts - comfortable in BD settings, client-facing conversations, and budget negotiations
Exceptional communicator who can move between scientific, operational, and executive registers with ease
COMPENSATION & BENEFITS:
Siteroproudly offers animpressive compensation package and benefits, including a competitive salary, paid time off, and healthcare and retirement perks.
EMPLOYMENT TYPE:
Full Time, Permanent
COMMITMENTS:
Standard Hours 40 hours per week, one hour lunch, Monday - Friday. Additional hours as needed.
3X per week working from our Mississauga office (Mon, Tues, Wed)
2X per week working from your home office remotely (Thurs, Fri)
Willing to work in shifts as and when needed.
DISCLAIMER:
Sitero is an equal opportunity employer and welcomes all job applicants. All qualified applicants will receive consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other factors prohibited by law.
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📌 Senior Director, Clinical Operations (Ontario)
🏢 Sitero
📍 Ontario