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Clinical Study Coordinator

hace 2 meses

Madrid, Madrid, España Mabxience A tiempo completo
Job Description

Mabxience is seeking a highly skilled Clinical Study Coordinator to join our team. As a Clinical Study Coordinator, you will be responsible for ensuring the smooth execution of clinical trials under your supervision.

Key Responsibilities:
  • Study Planning and Management: Develop and manage clinical trial plans, identifying potential deviations and communicating with the Medical Director to implement contingency plans and corrective measures.
  • CRO and Vendor Management: Participate in the selection and management of Contract Research Organizations (CROs) and external vendors, ensuring compliance with plans, timelines, and quality standards.
  • Site Selection and Management: Collaborate with the Medical Director and potential partners to identify and select research centers and investigators, ensuring the performance of the trial at each site.
  • Documentation and Approvals: Review and obtain necessary documentation from participating centers, ensuring approvals from Ethics Committees and Health Authorities.
  • Monitoring and Quality Control: Develop and maintain monitoring plans, ensuring the quality of participating centers and the control of blood samples for pharmacokinetic and/or pharmacodynamics studies.
  • Training and Support: Provide researchers with relevant information on clinical trials and ensure their continuous updating.
  • Amendments and Protocol Management: Elaborate and coordinate amendment documents to clinical trial protocols, ensuring approval and updating of new protocol versions.
Requirements:
  • Education: Degree in Health Sciences; Master's degree is a plus.
  • Languages: Fluent Spanish and English; knowledge of other languages is an asset.
  • Experience: +4 years of experience in a similar position, with international clinical trials experience.
  • Specific Knowledge: Knowledge of applicable law in international clinical trials is essential.
  • Personal Skills: Strong organizational and prioritization skills, detail-oriented, ability to perform database/literature searches; excellent interpersonal skills and effective team collaboration; clear, effective written and verbal communication skills; ability to work under pressure to meet tight deadlines; client-focused approach to work.