Study Start Up Specialist (with French)

About the role

The Study Start Up Specialist will support project management, regulatory, and contract/legal teams in all site‑related start‑up activities. Acting as the main contact for study sites, the specialist will ensure timely preparation, distribution, and follow‑up of start‑up documents while tracking progress using designated tools.

Key responsibilities

• Create and manage site‑specific start‑up document packages in collaboration with Project Management.
• Distribute packages to sites, follow up for executed documents, and review them for accuracy.
• Coordinate with Regulatory Affairs to secure complete packages within planned timelines.
• Serve as the primary point of contact for site contract and budget negotiations, working with Contract & Legal and Project Management.
• Maintain a site intelligence tracker covering timelines, budgets, contract milestones, and recruitment data.
• Plan and track start‑up actions, provide expected Site Initiation Visit (SIV) dates, and update progress in SmartSheet or CTMS.
• Ensure compliance with local regulatory requirements and support project management as needed.

Required profile

• Undergraduate degree (Bachelor or Honors) with less than 1 year experience, or College Diploma/Degree with 1‑3 years related experience.
• Excellent communication skills and a very high sense of urgency.
• Experience working directly with clinical study sites.
• Basic financial responsibility, such as handling small cash floats and contributing to budget creation.

Required skills

• Proficiency with SmartSheet.
• Experience using a Clinical Trial Management System (CTMS).