The Project Director is responsible for overseeing the conduct of a program or portfolio of clinical studies or large global multicenter trials with significant budgets. This role may involve studies for specific clients or a group within the same therapeutic area across multiple clients. The Project Director manages Project Managers handling projects of various sizes and complexities, from single-service studies to large, multi-protocol, global projects, or portfolios. The role includes leading operational contributions to proposal development and business activities with minimal oversight, leveraging therapeutic and project management expertise.
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This role will be perfect for you if :
* You are eager to contribute to the growth of a specialized CRO.
* You are a hands-on leader.
* You want to be involved in program management as well as line management.
RESPONSIBILITIES
* Oversee a portfolio or program of projects and the Project Managers managing those projects.
* Ensure all studies meet therapeutic or client-specific requirements.
* Represent the company to clients, maintaining satisfaction and effective communication of deliverables.
* Ensure studies comply with quality standards, SOPs, GCPs, regulatory requirements, and ICH guidelines.
* Manage contract execution and financial aspects, including budgets and expenses.
* Track project progress using timelines and analysis tools.
* Maintain and apply therapeutic and client-specific knowledge across the portfolio.
* Lead contingency planning and risk mitigation strategies.
* Contribute to proposal development and operational strategies.
* Drive performance improvements, operational efficiencies, and innovative strategies.
* Potentially provide line management and leadership within Project Management.
Requirements
Education
* Bachelor's degree in a relevant discipline; Master’s degree and certifications like PMP or PRINCE2 are assets.
Experience
* Minimum 15 years industry experience, with at least 5 years at a CRO.
* At least 10 years of clinical project management experience, including managing all project phases and functional services.
* Experience with multi-regional, multinational phase III trials and budget management.
* Leadership experience in mentoring and coaching project managers.
* Experience in business development activities.
* Dermatology experience is an asset.
Knowledge and skills
* Good knowledge of GCP, Health Canada, FDA regulations, and guidelines.
Work environment
At Indero, you will work with brilliant colleagues in a culture of collaboration, innovation, reliability, and responsiveness. The position is home-based in Germany, with regular travel required.
About Indero
Indero is a CRO specializing in dermatology and rheumatology, established in 2000, with a reputation for quality. Based in Montreal, the company is expanding in North America and Europe. We are committed to equal opportunity and accommodations for applicants with disabilities. Only applicants with legal work authorization in Germany will be considered.
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