Study Start-Up Project Manager
New
J
JobgetherClinical Research
CanadaFull-TimeManager
SalaryCompetitive compensation package with salary paid in local currency (CAD).
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Job Details
- Languages
- English
- Experience
- Minimum of 5 years
- Required Skills
- Project Management
Requirements
- 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.
Responsibilities
- 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.
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