Huidige banen gerelateerd aan Clinical Research Associate Lead - Amsterdam, Noord-Holland - Edwards Lifesciences
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Clinical Research Associate II
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Clinical Research Associate Lead
2 maanden geleden
We are seeking a highly experienced Clinical Research Associate Lead to join our team at Edwards Lifesciences. As a key member of our clinical operations team, you will be responsible for overseeing and coordinating clinical studies, ensuring compliance with regulatory requirements, and providing guidance to study teams.
Key Responsibilities:- Study Oversight: Organize and supervise clinical studies, providing oversight of trial activities, including protocol compliance, enrollment, monitoring deviations, and data quality.
- Leadership and Collaboration: Serve as a key contact for assigned clinical sites, ensuring proper project conduct, and collaborating closely with internal stakeholders.
- Training and Development: Develop and deliver training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, and study investigation protocols.
- Regulatory Compliance: Ensure regulatory and clinical protocol compliance is maintained, including reporting adverse events, protocol deviations, and device complaints in a timely manner.
- Process Improvement: Identify and implement new processes to improve study conduct and compliance.
- Mentorship: Act as a mentor to new or junior level employees, providing guidance and support in their professional development.
- Education: Bachelor's Degree in a related field, or Associate's Degree or equivalent in a related field with 7 years of experience.
- Experience: 5 years of previous related medical device and/or clinical experience, or 7 years of experience in field monitoring, quality assurance/control, and regulatory compliance.
- Skills: Proven expertise in MS Office Suite, strong written and verbal communication skills, presentation, and interpersonal relationship skills, including negotiating and relationship management skills.
- Experience: Experience working in a medical device or regulated industry, experience with electronic data capture, and experience in interventional cardiology or cardiothoracic surgery.
- Skills: Agile, dynamic, solution-focused traits, and experience with training and proctoring new employees.
