Clinical Project Manager
On-siteMontréal, Quebec, Canada
Job Summary
Lead cross-functional country- and regional-level study teams to ensure clinical supply and regulatory goals are aligned. Develop and maintain Country or Regional Execution Plans to ensure local site activation meets global milestones. Manage the execution of clinical trials as the primary liaison in assigned countries, overseeing operational implementation of protocols. Identify and qualify high-performing private research sites to diversify our profile beyond traditional academic centers. Navigate specific regional ethics landscapes to ensure competitive start-up at local sites. This role requires 8+ years of hands-on clinical research experience, 5+ years as a Project Manager, and 3+ years as a CRA. You will travel approximately 15% for co-monitoring and territory development. We offer equity, an annual bonus, and a $1,500 Active Lifestyle Allowance.
Required Qualifications
- 8+ years of relevant hands-on experience in clinical research
- Bachelor's degree in a related field
- 5+ years as a Project Manager leading multi-center trials
- 3+ years as a CRA
- Strong understanding of ICH-GCP
- Strong understanding of FDA/Health Canada regulations
- Experience managing Phase I-III clinical trials
- Experience with advanced CTMS platforms
- Experience with eTMF platforms
- Experience with EDC platforms
- Ability and willingness to travel (~15%) for co-monitoring/quality control visits and territory development
Desired Qualifications
- Outstanding communicator, team player, and relationship builder
- Passion for science, operational excellence, and innovation
- Attention to detail
- Timelines management
- Creative thinking
- Inspiration from working with teammates and partners to bring innovative medicines to patients
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