Remote Study Start-Up Project Manager - Canada
Core
Manage and execute all aspects of global clinical trial start-up for biotechnology, pharmaceutical, and medical device clients.
Role type
Senior Study Start-Up Project Manager (Clinical Operations)
Builds
Clinical trial start-up infrastructure and regulatory submissions
Domain
Clinical Research / Biopharma / Regulatory Affairs
Required skills
Global start-up management, Quality assurance of submission documents, Informed consent form preparation, Regulatory compliance (Health Canada, Ethics), ICH guidelines knowledge, Bid defense presentation
Preferred skills
French language proficiency
Technologies
Clinical trial management systems, Regulatory submission platforms
Responsibilities
Manage and execute global start-up activities, Perform quality checks on submission and site documents, Prepare and approve informed consent forms, Serve as Sponsor point of contact for regulatory submissions, Review regulations to solve start-up issues, Present at bid defenses and audits