Study Start-Up Project Manager

Accountabilities: As a Study Start-Up Project Manager, you will oversee global study start-up activities, ensuring regulatory submissions, documentation, and site activation processes are completed efficiently and in alignment with clinical trial requirements. You will serve as a key point of contact for start-up operations while supporting quality, compliance, and successful trial execution.

Manage and execute all aspects of global study start-up activities to support timely clinical trial initiation.

Perform quality reviews of submission packages, regulatory documents, and essential site documentation.

Prepare, review, and approve informed consent forms according to applicable requirements.

Act as a primary point of contact for sponsors regarding start-up activities and regulatory submission matters.

Review relevant regulations and guidelines to identify potential challenges and develop proactive solutions.

Coordinate with internal and external stakeholders to ensure alignment throughout the start-up process.

Participate in bid defenses, capability presentations, and audit activities when required.

Maintain high standards of quality, compliance, and operational efficiency across assigned studies.

Requirements:

The ideal candidate brings strong experience in clinical research operations, study start-up management, and regulatory submissions. You should have a solid understanding of clinical trial requirements and the ability to manage multiple priorities in a global environment.

Bachelor’s degree in a science, healthcare, or related field.

Minimum of 5 years of experience managing study start-up activities within a Contract Research Organization (CRO) environment.

Proven experience with Health Canada regulatory submissions and ethics committee submissions.

Strong knowledge of ICH guidelines, clinical research regulations, and applicable local requirements.

Experience managing clinical trial documentation, site activation processes, and regulatory workflows.

Strong organizational skills with the ability to prioritize tasks and meet deadlines.

Excellent communication and stakeholder management abilities.

Fluency in English required; proficiency in French is considered an advantage.

Ability to work independently while collaborating effectively with global teams.

Benefits:

Competitive compensation package with salary paid in local currency (CAD).

Competitive bonus program opportunities.

Potential sign-on bonus and equity award opportunities.

Flexible work environment.

Comprehensive medical and life insurance benefits.

Voluntary pension plan.

Competitive paid time off packages.

Structured career development paths with opportunities for professional growth.

Opportunity to contribute to impactful clinical research projects that improve patient outcomes.

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? 

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