Gestionnaire, Affaires réglementaires et démarrage
$103,000–$153,000 year
On-site · Toronto, Ontario, Canada or Mississauga, Ontario, Canada
Job Summary
Direct and manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award activities, oversight of scope of work, budget and resources. Oversee site activation (pre-award/bid defense) and/or maintenance for assigned projects, develop and implement the Management Plan within the agreed strategy, ensure collaboration across Regulatory & Site Activation with regions and countries, create/review technical and administrative documentation to support business development and study initiation/maintenance, provide regulatory and technical scientific support to facilitate efficient clinical trials while ensuring regulatory compliance, guide multi-regional/multi-protocol programs during start-up and maintenance, determine regulatory strategy for submissions, assess regulatory landscape, ensure internal systems (CTMS) and project plans are accurately maintained, mentor colleagues, and participate in client relations and potential monthly budget activities.
Required Qualifications
- Bachelor's Degree Life sciences or related field
- 7 years relevant experience in scientific or clinical environment including international experience
- Strong negotiation and communication skills
- Excellent interpersonal and team skills
- Proven ability to manage multiple complex projects
- Understanding of regulated clinical trial environment and drug development process
- Proficiency with systems/technology to achieve work objectives
- Regulatory/technical writing skills
- Knowledge of GCP and ICH guidelines
- Leadership skills to motivate, coach and mentor
- Organizational and planning skills
- Independent judgment with calculated risk taking
- Presentation skills
- Ability to establish/maintain working relationships with colleagues, managers and sponsors
- Understanding of study financial management
- Ability to balance multiple priorities
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