Study Start-Up Project Manager

Team: Project Management

Location: Canada

Commitment: Full-time

Workplace Type: remote

Accountabilities:

• Manage and successfully execute all aspects of global clinical study start-up activities, ensuring quality and timelines are maintained.
• Perform thorough quality checks of regulatory submission documents and essential site documentation.
• Prepare and approve informed consent forms in accordance with applicable requirements and study standards.
• Act as a key point of contact for sponsors regarding study start-up activities and regulatory submission matters.
• Review applicable regulations and guidelines to identify potential challenges and develop proactive, compliant solutions.
• Coordinate with internal and external stakeholders to address start-up issues and keep study activation activities progressing efficiently.
• Support bid defense meetings, general capabilities presentations, audits, and other business or quality-related discussions as required.

Requirements:

• Bachelor’s degree in a science, healthcare, life sciences, or another relevant field.
• At least 5 years of study start-up Lead or Manager experience within a contract research organization (CRO).
• Demonstrated experience managing study start-up activities involving Health Canada and Ethics submissions.
• Strong knowledge of ICH guidelines and applicable Canadian and local regulatory requirements.
• Proven ability to manage multiple priorities, timelines, and stakeholders in a complex clinical research environment.
• Strong organizational, problem-solving, and project management skills with a proactive approach to resolving challenges.
• Excellent written and verbal communication skills, with the ability to interact effectively with sponsors and cross-functional teams.
• Strong attention to detail and commitment to quality and regulatory compliance.
• Professional fluency in English is required; proficiency in French is considered an advantage.

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.
• Opportunities for professional development, ongoing training, and continuous learning.
• Defined career development paths and opportunities for advancement.
• Supportive, collaborative environment with accessible leadership and cross-functional collaboration.
• Opportunities to contribute to clinical research programs focused on advancing safe and effective medical treatments.
• Flexible work arrangements may be available for eligible positions, subject to applicable requirements and training.
• Company-sponsored social and team-building activities, where applicable.
• Benefits and eligibility may vary depending on location and employment terms.