Project Director, Early Phase and Translational Research

07 ott - Roma
Indero

Project Director Early Phase and Translational Research (EPTR), North America

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.

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