Overview
In this role you will oversee day-to-day operations of clinical studies in Leuven, Belgium, applying ICH/GCP standards within a CRO context. You will serve as the main sponsor contact for operational issues and study deliverables, while maintaining deep knowledge of protocols, therapeutic areas, and indications. You will coordinate a cross-functional project team, ensure training, and drive risk management and vendor oversight. This is a growth-focused opportunity in immunology and infectious diseases, with remote flexibility after probation and a competitive compensation package.
Pay / Benefits
- flexible work environment
- competitive compensation and benefits package
- competitive PTO
- structured career paths
- employee appreciation events
- employee health and wellness initiatives
Responsibilities
- Oversee day-to-day project operations per contract and regulatory requirements
- Act as primary sponsor contact for operational issues and study deliverables
- Maintain protocol and therapeutic area knowledge to guide study execution
- Provide cross-functional oversight and ensure necessary project training
- Review and input on study protocol, edit check specs, data analysis plan, and final report when applicable
- Develop operational project plans and manage risk assessment and execution
- Oversee vendor management for studies
- Ensure site quality and supervise CRAs and monitoring deliverables
Key requirements
- Bachelor in Health or Life Science; advanced degree preferred
- Phases 1-4 experience, with Phases 2-3 preferred
- Minimum 2 years of Clinical Trial Management experience; CRO experience preferred
- Experience managing overall project timelines
- Bid defense experience preferred
- Strong leadership skills
- strong leadership
- stakeholder management
- effective communication
- ICH/GCP knowledge
- protocol and data analysis plan review
- vendor management
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