Project Director, Dermatology & Rheumatology CRO, Canada

The Project Director is responsible for oversight of the conduct of a program or portfolio of clinical studies or large global multicentered trials with large study budgets. The portfolio may comprise studies for specific customers, and/or a group of studies within the same therapeutic area or indication for more than one customer. The Project Director oversees Project Managers (PMs) who are managing projects ranging in size and complexity from single service studies to large full scope, multiple protocol projects, global projects and/or portfolio of projects. The Project Director leads the operational contribution to proposal development and business development activities at a project level with minimal oversight directly applying their therapeutic and project management expertise This role will be perfect for you if: You are looking to contribute your expertise to the growth of a specialized CRO You are a hands-on leader You have at least 10 years of clinical project management experience, including management of all projects phases from start up to closure, management of all functional services, vendor management. You have experience in dermatology or rheumatology trials is required RESPONSIBILITIES Oversees a portfolio or program of projects and the Project Managers assigned to operationalize the awarded studies. Ensures all studies within a program or portfolio are conducted to reflect the therapeutic or client specific requirements. Represents company to the customer, ensuring satisfaction levels are maintained and program deliverables are communicated effectively. Ensures the study is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) or appropriate regulatory requirements, and International Conference on Harmonization (ICH) guidelines to fulfil all federal and local regulations. Oversees the management of the executed contract and financial aspects of assigned projects, including reviewing study budgets and expenses. Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools. Ensures and maintains an in depth therapeutic and/or client specific knowledge and expertise for the assigned portfolio. Applies study specific learning across assigned portfolio of studies/clients. Leads and ensures consistency in contingency planning and risk mitigation strategies to ensure successful delivery. May lead operational input to proposal development and pricing including proposed operations strategy Drives performance improvement, operational efficiencies and innovative strategies May provide line management oversight and contribute to leadership of Project Management as an operational and therapeutic area expert Requirements IDEAL PROFILE Education Bachelor of Science in a relevant discipline. A Master’s degree is an asset. PMP or PRINCE2 Certification is an asset Experience 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 projects phases from start up to closure, management of all functional services, vendor management. Experience with mid-size and large studies (>10-15 countries) in multiple regions (NA, SA, APAC, MENA, Europe) is desirable. Experience leading concurrent multi-centered, 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, such as development of proposals, client presentations, bid defense meetings, and the like Participation in mentoring and coaching of a representative number of project managers Dermatology or rheumatology experience is required Knowledge and skills Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines Our company The work environment At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. In this position, you will be eligible for the following perks: Flexible work schedule / work schedule : Home-based position Ongoing learning and development About Indero Indero is a CRO specialized in dermatology and Rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to grow and expand in North America and Europe. Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request. Indero only accepts applicants who can legally work in North America Description de poste null Profil recherché null Notre entreprise null

The Project Director oversees a portfolio of clinical studies, managing project managers and ensuring adherence to quality standards and regulatory requirements. They also lead operational contributions to business development, proposal pricing, and client satisfaction.

Candidates must have at least 10 years of clinical project management experience, including expertise in dermatology or rheumatology trials. A Bachelor of Science degree is required, and professional certifications like PMP or PRINCE2 are considered an asset.

• Flexible work schedule • Home-based position • Ongoing learning and development

• Regulatory ComplianceSouhaitée
• CoachingSouhaitée
• Team LeadershipSouhaitée
• Google CloudSouhaitée
• Business developmentSouhaitée
• ForecastingSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Clinical project management
• Dermatology
• Rheumatology
• Vendor management
• Budget management
• Risk mitigation
• Proposal development
• Business development
• GCP
• ICH guidelines
• Regulatory compliance
• Team leadership
• Mentoring
• Coaching
• Clinical trials
• Forecasting
• FDA Regulations
• Proposal Development
• Risk Mitigation
• Financial Tracking
• Research
• Drug Administration
• Business Development
• Management
• Clinical Trials
• Contingency Planning
• Standard Operating Procedure
• Leadership
• Good Clinical Practices (GCP)
• Innovation
• Project Management
• Mentorship
• Operations
• Performance Improvement
• Phases Of Clinical Research
• Presentations
• PRINCE2 (PRojects IN Controlled Environments 2)
• Quality Management
• Timelines
• Reliability
• Vendor Management
• ICH Guidelines

• Healthcare
• Management & Leadership
• Science & Research
• Consulting
• Rheumatology Specialist
• Project Manager (General)
• Management and Organization Analysts
• Project Management Specialists

Formation minimale

Baccalauréat

Expérience minimale

10+ ans

Langue de l’offre

anglais

Heures de travail

40 heures par semaine