Country Study Operations Manager – Clinical Trial Manager

This is a fully remote position, open to applicants in Canada.

📋 Description

• Lead local study teams for one or more clinical trials.

• Provide support for or take on Global Study Manager duties as necessary.

• Supervise CROs and/or Country Trial Managers/Site Care Partners at the country level.

• Manage and uphold country-level timelines, budgets, risk plans, and quality plans.

• Oversee or manage study startup activities within designated countries.

• Coordinate submission strategies with site, activation, and regulatory teams for Health Authorities and Ethics Committees.

• Offer country-specific insights on startup and recruitment milestones.

• Identify and address study startup and execution deviations and risks, implementing appropriate mitigation strategies.

• Resolve escalations related to site activation and provide options for mitigation.

• Execute startup and site activation strategies at the regional, country, and study levels.

• Create regional, country, and study-level recruitment strategies and plans.

• Communicate effectively with local teams, internal stakeholders, and CROs to ensure timely delivery of studies.

• Manage and oversee study and country vendors, including coordination of their deliverables.

• Coordinate follow-up on quality events, protocol deviations, data issues, metrics, site issues, risks, and audit responses.

⛳️ Requirements

• A Bachelor of Science or Bachelor of Arts degree with at least 5 years of relevant operational clinical trial experience is required.

• A Master of Science or Master of Business Administration degree with a minimum of 3 years of relevant operational clinical trial experience is required.

• A scientific or technical degree is preferred.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Flexible work arrangements and a supportive work environment.