18 sep
|
Jobrapido
|
España
Overview
Se pueden requerir diversas habilidades interpersonales y experiencia para el siguiente puesto. Por favor, asegúrese de consultar la descripción a continuación con atención.
In this role you will guide late-phase Hematology/Immunology trials as a sponsor-side Clinical Project Manager II. You’ll coordinate with CROs and vendors, drive study timelines, and oversee documentation and risk management. You’ll partner with cross-functional teams to ensure trial deliverables meet SOP, GCP, and regulatory standards. This position offers integral scope and a chance to shape pivotal studies within a mission-driven organization.
Responsabilidades
- Support the Clinical Trial Manager/operational team in trial execution
- Liaise with CROs and ancillary vendors to manage trial tasks
- Maintain effective communication with the project team and provide status reports to align with timelines
- Review, develop, and write clinical trial documents and manuals (study manuals, biomarker plans)
and create Master ICF template
- Review and approve site changes in consultation with legal and safety when warranted; update templates for risks and amendments information
Requisitos principales
- Prior sponsor-side experience
- Global study experience
- Oncology, Hematology, or Immunology therapeutic area expertise, ideally with complex/pivotal studies
- End-to-end study management experience
- Strong xqbhyrx communication skills in a fast-paced environment
- Proactive ownership
- Strong communication and collaboration with internal teams, sites, and vendors
- Strong prioritization and organizational skills
- Clinical trial documentation development
- Master ICF template creation
- Site and vendor coordination
Hay opciones de teletrabajo/trabajo desde casa disponibles para este puesto.
📌 Single Sponsor Clinical Project Manager II (España)
🏢 Jobrapido
📍 España