דרושים Clinical Trial Manager בכל הארץ

Magenta is medical device company developing a miniaturized catheter-mounted pump, to support the heart in cases of acute heart failure and high-risk percutaneous coronary interventions. Magenta’s pump is a best-in-category device combining the smallest insertion size and the highest flow. The Magenta system is multi-disciplinary, including mechanical engineering, material science, electrical engineering, software, algorithms and state-of-the-art catheter fabrication techniques.

We are seeking a Clinical Trial Manager to join our Clinical Affairs team.

Reports to: Sr. Director of Clinical Affairs

• 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 EDC.
• Preparation of clinical regulatory document packages for EC and HA submissions, 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.
• Coordinate and provide case support to the physicians in clinical trial procedures in compliance with Good Clinical Practice (GCP), regulatory guidelines, and protocols.
• Responsible for training the clinical site personnel and investigators on the proper use of the Elevate System via education sessions and case support.
• Logistics coordination for cases, clinical trial device inventory.
• Ability to travel in Israel up to 50% and 40% abroad.

Qualifications:

• A bachelor’s degree in nursing, or a related field - must.
• Clinical care nurse from hospital setting 4+ years - must.
• Experience managing clinical trials in the medical device Industry.(experience with invasive medical devices - an advantage).
• 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