Project Director overseeing dermatology and rheumatology clinical trials for specialized CRO Indero. Managing global study portfolios, project managers, budgets, quality, and client delivery.
Responsibilities
Oversee a portfolio or program of clinical study projects and the Project Managers assigned to them
Ensure studies meet therapeutic-area or client-specific requirements
Represent the company to customers and maintain satisfaction levels
Communicate program deliverables effectively
Ensure studies follow quality standards, SOPs, GCPs, regulatory requirements, and ICH guidelines
Oversee executed contracts and project financial aspects, including budgets and expenses
Maintain and evaluate project progress, timelines, and tracking/analysis tools
Maintain therapeutic-area and client-specific knowledge for the assigned portfolio
Apply study-specific learning across assigned studies and clients
Lead contingency planning and risk mitigation strategies
Provide operational input to proposal development, pricing, and operations strategy
Drive performance improvement, operational efficiencies, and innovative strategies
Provide line-management oversight and contribute to Project Management leadership as an operational and therapeutic-area expert
Requirements
Bachelor of Science in a relevant discipline
PMP or PRINCE2 Certification is an asset
At least 15 years industry experience and a minimum of 5 years at a CRO
At least 10 years of clinical project management experience, including management of all project phases from start-up to closure, all functional services, and vendor management
Experience with dermatology or rheumatology trials is required
Experience with mid-size and large studies (>10-15 countries) in multiple regions is desirable
Experience leading concurrent multicentered, multinational Phase III clinical trials, including project budget financial tracking and forecasting
Substantial experience in project supervision, mentoring, and coaching project managers
Substantial experience with business development tasks, including proposals, client presentations, and bid defense meetings
Good knowledge of Good Clinical Practices and applicable Health Canada and FDA regulations/guidelines
Must be legally able to work in North America
Benefits
Flexible work schedule
Home-based position
Ongoing learning and development
Attractive advancement opportunities
Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request
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