Study Operations Manager - Canada Remote

ICON Strategic Solutions; Canada; Remote; CAD 80,000 - 110,000; Full time

Job summary

ICON Strategic Solutions is seeking a C-SOM to oversee clinical studies from initiation to completion. The role involves managing study activities, ensuring compliance, and leading teams within a diverse and inclusive environment. Candidates should have significant experience in clinical trials and relevant educational background, complemented by competitive compensation and benefits.

Benefits

Competitive salary

Health insurance

Retirement plans

Flexible country-specific options

Qualifications

• Experienced in operational clinical trials.
• Relevant scientific or technical degree preferred.
• Knowledgeable in regulatory operations.

Responsibilities

• Manage and oversee study activities from startup through closeout.
• Support site identification and ensure compliance with regulations.
• Manage quality events and coordinate vendor activities.

Skills

Good Clinical Practice

Project Management

Communication

Education

BA/BS degree

MBA/MS degree

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 from startup through conduct and closeout at regional/country levels.
2. Potentially manage study startup processes in assigned countries or oversee pCRO responsible for these activities.
3. Support site identification, feasibility, and outreach processes with Site Care Partner/Country Trial Manager or pCRO to ensure sites meet protocol requirements.
4. Provide country-level input on startup and recruitment milestones during planning stages.
5. Supervise pCRO and/or Country Trial Manager/Site Care Partner for assigned studies, maintaining accurate plans and managing risks and deviations.
6. Collaborate with key roles to resolve escalations and implement mitigation strategies.
7. Lead the local study team and ensure compliance with global and local regulations.
8. Facilitate communication between global and local teams.
9. Provide protocol guidance and liaise with regulatory and site partners on submission strategies.
10. Utilize local intelligence to inform risk management and ensure audit readiness.
11. Manage quality events, site recruitment, data cleaning, and other operational deliverables.
12. Support implementation of new systems and technologies.
13. Coordinate vendor management, investigator meetings, and other operational activities.
14. Ensure all study documentation and systems (PTMF, ISF) are complete and compliant.
15. Support submission responses and regulatory activities.
16. Contribute to operational efficiency initiatives and act as SME if needed.

You are:

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

Education:

• Relevant clinical trial operational experience.
• Preferred degrees include scientific or technical backgrounds.
• Experience in study management, supervision of CROs, and cost management.

What ICON offers:

Competitive salary, extensive benefits, and a diverse, inclusive work environment. Benefits include leave entitlements, health insurance, retirement plans, employee assistance programs, life insurance, and flexible country-specific options.

Visit our website for more: https://careers.iconplc.com/benefits

ICON is an equal opportunity employer committed to an inclusive environment. Applicants requiring accommodations should contact us through the provided link.