Clinical Research Project Manager
hace 3 semanas
We are seeking a Senior Study Start Up Associate to join our team. This role is crucial in leading the initiation of clinical trials, ensuring compliance with regulatory requirements and contributing to the advancement of innovative treatments and therapies.
Key Responsibilities:- Preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions and regulatory agency communications.
- Coordination and liaison with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
- Management and maintenance of comprehensive and accurate records of regulatory submissions, approvals and correspondence.
- Guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
- Bachelor's degree in life sciences or related field.
- Minimum 2 years of experience in clinical research or regulatory affairs with specific experience in study start-up activities.
- Strong understanding of regulatory requirements and guidelines for clinical trials including ICH-GCP and local regulatory requirements.
- Excellent organizational and project management skills with ability to prioritize and manage multiple tasks simultaneously.
We offer a competitive salary, annual leave entitlements, range of health insurance offerings, retirement planning, Employee Assistance Programme, life assurance and flexible country-specific benefits.
About Us:At ICON Plc, diversity, inclusion and belonging are fundamental to our culture and values. Our rich diversity makes us more innovative, which helps us better serve our people, patients, customers and communities.
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Clinical Research Portfolio Manager
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Clinical Research Project Manager
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Clinical Research Project Lead
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Clinical Study Manager
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Clinical Research Project Manager
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Project Manager
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Madrid, Madrid, España Syneos Health, Inc. A tiempo completo**Company Overview:**Syneos Health, Inc. is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of...
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Clinical Research Project Lead
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Madrid, Madrid, España Ora A tiempo completoUnlock Your Potential as a Clinical Project ManagerOra is revolutionizing the ophthalmic clinical research industry, and we're seeking a seasoned Clinical Project Manager to drive our mission forward. As a key member of our team, you will play a critical role in delivering high-quality clinical trials that meet regulatory requirements.Our Company OverviewAt...