Global Site Activation & Start-Up Expert

AbbVie Inc.; Montreal; On-site; CAD 85,000 - 120,000; Full time

Benefits offered by this job

Innovative work culture

Professional development

Paid time off: vacation, holidays, and

Employee stock purchase

Wellness spending account

Flexible health insurance

Retirement savings programs

Bonus plan

Job summary

AbbVie Inc. in Montreal, QC, seeks a Specialist, Country Study Start Up to drive start-up and maintenance activities across studies in assigned countries. You will act as an SME for SSU, ensuring regulatory alignment, site activation, and timely IP release.

The role requires collaboration with cross-functional teams, strong problem solving, and fluency in French and English to support regulatory and IRB/EC processes.

Qualifications

• Bachelor's degree in Health Care or Science (preferred).
• At least 3 years of clinical research experience and start-up management.
• Experience interpreting regional clinical research regulations and processes.
• Experience with central and local IRB/EC sites, including ICF review routing.
• Adept with Vault SSU for essential documents, IP release, and ICf/IRB review.
• Experience with remote/virtual teams.
• Strong analytical and critical thinking skills.
• Fluent in French and English (oral and written).

Responsibilities

• Ensure successful, on-time, high-quality start-up and maintenance activities for sites/studies.
• Establish activation plans and risk mitigation with cross-functional teams.
• Proactively identify issues and propose solutions.
• Attend regional start-up calls and provide input.
• Coordinate with Regulatory and CMS on submissions and approvals.
• Lead training and mentoring of Country Start Up Specialists.

Skills

French and English (bilingual)

Analytical thinking

Interpersonal skills

Start-up leadership

Issue identification & solutioning

Education

Bachelor's degree in Health Care or Science

Tools

Vault SSU

Job description

AbbVie Inc. in Montreal, QC, seeks a Specialist, Country Study Start Up to drive start-up and maintenance activities across studies in assigned countries. You will act as an SME for SSU, ensuring regulatory alignment, site activation, and timely IP release.

The role requires collaboration with cross-functional teams, strong problem solving, and fluency in French and English to support regulatory and IRB/EC processes.