Study Operations Manager I (cSOM1)

ICON; Canada; Remote; CAD 60,000 - 100,000; Full time

Job summary

Join an innovative leader in clinical research as a C-SOM, where you will manage and oversee study activities while collaborating with diverse teams. This role offers a unique opportunity to contribute to the success of clinical trials, ensuring compliance and effective communication across stakeholders. You will leverage your expertise in operational clinical trials and regulatory practices while enjoying a supportive and inclusive workplace culture. With competitive salaries and comprehensive benefits, this position is ideal for those passionate about making a difference in healthcare research.

Benefits

Health Insurance

Retirement Plans

Wellbeing Programs

Various Leave Entitlements

Qualifications

• 5+ years of experience in operational clinical trials.
• Knowledgeable in regulatory operations and clinical trial methodology.

Responsibilities

• Manage and oversee study activities from startup through closeout.
• Coordinate site recruitment, data cleaning, and vendor relationships.

Skills

Operational Clinical Trials

Good Clinical Practice

Regulatory Operations

Clinical Trial Methodology

Project Management

Education

BA/BS in a relevant scientific or technical field

MBA/MS

Job description

As a C-SOM, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

What you will be doing:

1. Manage and oversee study activities at the regional/country level from startup through conduct and closeout.
2. Manage study startup processes in assigned countries or oversee pCRO responsible for these activities.
3. Support outreach to sites and investigators, site identification, and feasibility to meet protocol requirements.
4. Provide country-level input on startup and recruitment milestones to the Global Study Manager.
5. Oversee pCRO and/or Country Trial Manager/Site Care Partner, managing country plans, timelines, budgets, risks, and quality.
6. Collaborate to identify and manage deviations and risks, implementing mitigation strategies and resolving escalations.
7. Lead the Local Study Team, including core and ad hoc members, ensuring compliance and effective communication.
8. Coordinate with country stakeholders on submission strategies and local intelligence gathering.
9. Act as the study-level point of contact, ensuring issue resolution and trend analysis for process improvements.
10. Contribute to risk assessment, quality management, and audit readiness activities.
11. Coordinate site recruitment, data cleaning, and manage costs and vendor relationships.
12. Support implementation of new systems and technology in trials.
13. Assist with regulatory submissions, document management, and supply management.
14. Support investigator meetings and local vendor management.

You are:

• Experienced in operational clinical trials.
• Possessing a relevant scientific or technical degree; BA/BS with 5+ years or MBA/MS with 3+ years of experience.
• Knowledgeable in Good Clinical Practice, regulatory operations, and clinical trial methodology.
• Fluent in English.

What ICON can offer you:

We value our people and foster a diverse culture that rewards high performance and nurtures talent. Our benefits include competitive salaries, various leave entitlements, health insurance, retirement plans, and wellbeing programs. Visit our careers website for more information.

ICON is committed to inclusion and diversity. We provide an accessible, discrimination-free workplace and consider all qualified applicants equally.

Interested but unsure if you meet all requirements? We encourage you to apply — you might be exactly what we’re looking for, whether for this or other roles at ICON.