Project Director, Early Phase and Translational Research
New
J
JobgetherClinical Research, CRO
Spain; remote working flexibility across EuropeFull-TimeDirector
Salary not disclosed
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Job Details
- Experience
- At least 15 years of relevant industry experience, including 5 years in a CRO environment and 10 years of clinical project management experience.
- Required Skills
- Business DevelopmentRisk Management
Requirements
- Bachelor’s degree in a relevant scientific or professional discipline.
- At least 15 years of relevant industry experience, including a minimum of 5 years within a Contract Research Organization (CRO) environment.
- At least 10 years of clinical project management experience covering the complete study lifecycle from start-up through closeout.
- Proven experience leading concurrent multicenter, multinational Phase III clinical trials, including financial tracking, forecasting, and budget management.
- Demonstrated experience managing functional services, external vendors, budgets, timelines, and operational delivery across complex clinical programs.
- Experience managing mid-size to large multinational studies spanning multiple regions.
- Required therapeutic experience in dermatology or rheumatology.
- Strong knowledge of Good Clinical Practice (GCP) and applicable regulatory requirements, including relevant FDA and Health Canada regulations.
- Substantial experience supervising, mentoring, and coaching Project Managers.
- Strong business development experience, including proposal development, client presentations, and bid defense meetings.
- PMP or PRINCE2 certification is desirable.
Responsibilities
- Oversee a portfolio or program of clinical studies and provide operational direction to the Project Managers responsible for delivery.
- Ensure studies are conducted in accordance with therapeutic requirements, client expectations, quality standards, SOPs, GCP, ICH guidelines, and applicable regulatory requirements.
- Act as a senior point of contact for customers, maintaining strong relationships, communicating program progress, and ensuring expectations and deliverables are consistently managed.
- Provide oversight of study contracts, budgets, expenses, financial tracking, forecasting, and overall project performance.
- Monitor timelines, milestones, risks, dependencies, and key performance indicators using appropriate project tracking and analysis tools.
- Maintain deep therapeutic and client-specific knowledge across the assigned portfolio and apply lessons learned consistently across studies.
- Lead contingency planning, risk mitigation, and proactive issue resolution to support successful study delivery.
- Oversee complex multinational and multicenter studies, including coordination of functional services and external vendors.
- Contribute operational expertise to proposal development, pricing, operational strategy, client presentations, and business development activities.
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