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Added 13 mins ago
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Added 13 mins ago
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Sitero LLC

Senior Director, Clinical Operations

Mississauga, ON, L4W 5L1, Canada

Job type: Full-time
Experience: 12+ years of clinical research experience, with at least 5 in a leadership role within a CRO or full-service sponsor environment
Working hours: 40 hours per week
Posting language: English
Posted: Sep 25, 2026

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Original 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)

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:

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.

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More about this job

Responsibilities

The Senior Director of Clinical Operations will oversee the end-to-end delivery of clinical programs, ensuring adherence to timelines, budgets, and quality standards. They will also build and refine operational infrastructure, lead the clinical operations team, and partner with business development to support client acquisition.

Requirements

Candidates must have at least 12 years of clinical research experience, including 5 years in a leadership role within a CRO or sponsor environment. Strong expertise in trial phases I-IV, risk-based monitoring, and clinical trial technology platforms is required.

Skills

Clinical operations
Project management
Risk-based monitoring
Strategic planning
Budget management
Regulatory compliance
Team leadership
Clinical trial management
SOP development
Capacity planning
Stakeholder management
Business development
Quality assurance
Clinical research
Vendor management
Data management

Benefits

Paid time off
Healthcare benefits
Retirement benefits

Visa sponsorship

Not detected in the job text

Keywords

Clinical Operations
CRO
Clinical Trials
Phase I-IV
EDC
CTMS
eTMF
Risk-based Monitoring
SOPs
Regulatory Affairs
FDA
EMA
ICH E6 R3
Project Management
Business Development
Life Sciences
Quality by Design
Inspection Readiness
Portfolio Management
Clinical Research Associate
Clinical Trial Manager
Strategic Leadership
Budgeting
Stakeholder Engagement
Capacity Planning
Performance Metrics
Therapeutic Areas
Compliance
Innovation
Clinical Services

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