Study Start-Up Project Manager

Overview

This position is open with a partner company based in Canada that manages the application and selection processes. The Study Start-Up Project Manager will play an essential role in the successful launch of global clinical trials by leading study start-up activities from the initial planning phase through execution.

Collaborating closely with sponsors, regulatory teams, and clinical operations stakeholders, you will ensure efficient and compliant site activations. Your role requires exceptional organizational capabilities, comprehensive knowledge of regulatory standards, and a proactive approach to resolving complex start-up challenges.

By contributing to the acceleration of innovative medical treatment development, you will uphold the highest quality standards. This role is suited for experienced clinical operations professionals who thrive in a dynamic, global setting and seek to join a team that values operational excellence, career growth, and meaningful contributions to healthcare research.

Key Responsibilities

• Lead and manage the comprehensive execution of global study start-up activities to facilitate prompt clinical trial commencement.
• Conduct thorough quality assessments of submission packages, regulatory documentation, and site-essential documents.
• Prepare, review, and authorize informed consent forms in compliance with relevant regulations.
• Serve as the main contact point for sponsors regarding start-up tasks and regulatory submission processes.
• Analyze applicable regulations and guidelines to foresee potential hurdles and implement strategic solutions.
• Coordinate effectively with internal departments and external partners to ensure synchronized start-up operations.
• Participate as needed in bid defenses, capability demonstrations, and audit functions.
• Maintain rigorous standards of quality, regulatory adherence, and operational efficiency for assigned studies.

Candidate Requirements

• Bachelor's degree in science, healthcare, or a related discipline.
• At least 5 years of demonstrated experience in managing study start-up tasks within a Contract Research Organization (CRO) environment.
• Proven expertise in Health Canada regulatory submissions and ethics committee applications.
• Strong understanding of ICH guidelines, clinical research regulations, and relevant local standards.
• Experience handling clinical trial documentation, site activation workflows, and regulatory procedures.
• Excellent organizational skills with the capacity to handle multiple priorities and meet deadlines.
• Exceptional communication skills and ability to manage stakeholder relationships.
• Fluency in English mandatory; French language skills are considered an advantage.
• Capability to work autonomously while maintaining productive collaboration with global teams.

Benefits and Perks

• Competitive salary paid in Canadian dollars.
• Attractive bonus programs.
• Potential eligibility for sign-on bonuses and equity awards.
• Flexible working conditions.
• Comprehensive medical and life insurance coverage.
• Voluntary pension scheme.
• Generous paid vacation and time off.
• Structured paths for career development and professional advancement.
• Opportunity to contribute meaningfully to clinical research projects that enhance patient care outcomes.

Additional Information

The recruitment process incorporates AI-assisted candidate matching to ensure an objective, fast, and fair evaluation of applications against the essential requirements of the role. Shortlisted candidates proceed directly to the hiring partner, who manages subsequent interviews and assessments. Personal data processing complies with relevant data protection regulations, and AI tools are used solely to support, not replace, human hiring decisions.