Study Start Up Specialist (with French)

About the role

The Study Start Up Specialist supports project management, regulatory, and contract/legal teams in all site‑related start‑up activities. Acting as the main contact for study sites, you will ensure timely preparation, distribution, and follow‑up of start‑up documents while maintaining strong relationships with site personnel.

Key responsibilities

• Create and manage site‑specific start‑up document packages in collaboration with Project Management.
• Distribute packages, obtain executed documents, and verify their correctness against internal standards.
• Coordinate with Regulatory Affairs to secure complete packages within planned timelines.
• Facilitate contract and budget negotiations, acting as the primary liaison for sites.
• Maintain a site intelligence tracker covering timelines, budgets, contract milestones, and recruitment data.
• Provide input for site selection based on past experience and intelligence.
• Plan and track start‑up actions, forecast Site Initiation Visit (SIV) dates, and monitor progress using SmartSheet or a 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 of related experience, or a college diploma with 1‑3 years of experience.
• Excellent communication skills and a very high sense of urgency.
• Experience working directly with clinical study sites and knowledge of site start‑up requirements.
• Ability to handle small financial responsibilities such as cash floats and contribute to budget creation.

Required skills

• SmartSheet
• CTMS