Senior Director Clinical Operations

Sitero; Mississauga; Hybrid; CAD 170,000 - 210,000; Full time

Job summary

Sitero is seeking a strategic, hands-on Senior Director of Clinical Operations to be the operational backbone of the CRO offering in Mississauga. You will own end-to-end delivery of clinical programs across client portfolios, setting the standard for trial execution and building the infrastructure, talent, and processes to scale with quality.

You will lead cross-functional efforts with business development, regulatory, data management, and site engagement to deliver trials sponsors trust and

Qualifications

• 12+ years of clinical research experience with leadership in CRO or full-service sponsor environment.
• Deep expertise across trial phases I–IV and therapeutic areas.
• Ability to build and scale clinical operations functions.
• Track record delivering multi-study portfolios on time and within budget.

Responsibilities

• Oversee end-to-end clinical program delivery across I–IV for multiple studies.
• Define SOPs, capacity planning, and real-time portfolio metrics.
• Lead the selection, implementation, and optimization of clinical systems (EDC, CTMS, eTMF, risk-based monitoring tools).
• Recruit, develop, and retain a high-performing clinical operations team—CRAs, CTMs, Sr. and Project Directors.
• Partner with BD, regulatory, data management and site engagement to deliver trials.
• Ensure risk-based monitoring and inspection readiness; coordinate sponsor audits and inspections.

Tools

EDC

CTMS

eTMF

RBM tools

Job description

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

We are seeking a strategic, hands-on Senior Director of Clinical Operations to serve as the operational backbone of Sitero's full-service CRO offering. This leader will own the end-to-end delivery of clinical programs across our client portfolio, set the standard for how Sitero executes trials, and build the infrastructure, talent, and processes that allow us to scale with quality.

You will be a working leader who shapes how Sitero operates every day — partnering closely with business development, regulatory, data management, and site engagement to deliver trials that sponsors trust and patients benefit from.

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)
• 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:

Sitero proudly offers an impressive compensation package and benefits, including a competitive salary, paid time off, and healthcare and retirement benefits.

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.