Senior Manager, Clinical Project Management
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De functie
Lead a clinical trial program focused on pediatric pulmonary valve disorders, directing planning through execution.
Ensure regulatory compliance and alignment with GCP, SOPs, and applicable clinical guidelines.
Develop and manage clinical project plans, identifying milestones and ensuring successful delivery of all trial deliverables.
Provide direction to core teams, oversee vendor and study site selection, and optimize resources and priorities.
Monitor trial performance, manage risks, implement corrective actions, and mentor team members.
Communicate results to stakeholders, support regulatory submissions, and oversee CTMS/eTMF usage; travel up to 30%.
Ensure regulatory compliance and alignment with GCP, SOPs, and applicable clinical guidelines.
Develop and manage clinical project plans, identifying milestones and ensuring successful delivery of all trial deliverables.
Provide direction to core teams, oversee vendor and study site selection, and optimize resources and priorities.
Monitor trial performance, manage risks, implement corrective actions, and mentor team members.
Communicate results to stakeholders, support regulatory submissions, and oversee CTMS/eTMF usage; travel up to 30%.
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