Come Work With Us!
Magenta Medical is a medical device company developing the world’s smallest heart pump, meant to provide minimally-invasive support to the heart during acute episodes of dysfunction. The Elevate™ System is multi-disciplinary, involving mechanical engineering, material science, electrical engineering, software, algorithms, and state-of-the-art catheter fabrication techniques.
We are seeking exceptional individuals to help drive the Elevate™ System forward and potentially save more lives.
We are seeking a talented Clinical Trials Manager to join our Clinical Affairs team.
Executing international multi-center clinical trials, from submission to composing final reports. Leading activities from pre-market clinical trials through post-market evaluations for determination of product safety and effectiveness, in compliance with applicable clinical and regulatory standards and in alignment with company objectives.
Reports to: Vice President of Clinical Affairs.
Responsibilities
• Execute the clinical trial and oversee the clinical trial management team while ensuring trials are compliant with all applicable regulations, company procedures, and ethical/quality standards.
• Management of clinical trial sites/CROs/core labs.
• Develop and manage clinical study plans to complete the clinical trial successfully meeting the milestones within required timelines.
• Work with the CRO to develop eCRF and EDC.
• Preparation of clinical regulatory document packages for IRB/EC submissions in US/EU, as applicable.
• Manage project status and analyze trial performance.
• Anticipate and communicate study risks/issues and lead implementation of the mitigation strategies.
• Preparation of portions of the clinical sections of regulatory submissions and study reports.
Qualifications
• Bachelor’s degree. An advanced degree in life sciences is an advantage.
• At least 7 years of experience managing clinical trials in the medical device Industry.(experience with invasive medical devices – an advantage).
• Proven track record in leading international multi-center studies.
• Experience in interventional cardiology and familiarity with invasive cardiac therapies – an advantage.
• Experience preparing submissions to regulatory agencies globally – an advantage.
• Experience corresponding with regulatory agencies – an advantage.
• GCP certified, CRA- advantage.
Desirable Skills:
• English – full proficiency.
• High verbal and writing skills.
• High self-learning ability.
• Independent and responsible person.
• Strong execution, communication and interpersonal skills.
Don’t see the position you’re looking for? We would still love to hear from you!