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.

About the Job

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.

 

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