Study Start-Up Project Manager

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Study Start-Up Project Manager based in Canada.

This role offers an opportunity to lead critical study start-up activities within a growing clinical research environment. You will oversee the successful execution of global study start-up activities, helping clinical trials move efficiently from planning into activation. The position combines regulatory expertise, document quality oversight, stakeholder coordination, and proactive problem-solving. You will work closely with sponsors and cross-functional clinical operations teams to manage submissions and resolve start-up challenges. Your expertise will contribute directly to maintaining quality, compliance, and timelines across clinical development programs. The environment is collaborative and fast-paced, with opportunities to contribute to audits, proposals, and strategic study discussions.

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.

How Jobgether works: We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team. We appreciate your interest and wish you the best!  Why Apply Through Jobgether?    Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.     #LI-CL1