Study Start-Up Project Manager

📋 Description

• Lead global study start-up activities ensuring quality and timelines.
• Quality check regulatory submission documents and site docs.
• Prepare and approve informed consent forms per requirements.
• Act as contact for sponsors on start-up and submission matters.
• Review regulations to identify challenges and develop compliant solutions.
• Coordinate with stakeholders to progress study activation and address issues.

🎯 Requirements

• Bachelor’s degree in science, healthcare, life sciences, or related field.
• At least 5 years of study start-up lead/manager experience within a CRO.
• Experience managing start-up activities involving Health Canada and Ethics submissions.
• Strong knowledge of ICH guidelines and Canadian/local regulatory requirements.
• Proven ability to manage multiple priorities, timelines, and stakeholders.
• Strong organizational, problem-solving, and project management skills; proactive.

🎁 Benefits

• Competitive compensation with performance-based bonus opportunities.
• Potential sign-on bonus and equity awards, depending on eligibility.
• Comprehensive health and wellness benefits.
• Retirement and paid time-off benefits.
• Professional development, ongoing training, and continuous learning.
• Defined career development paths and advancement opportunities.