Clinical Trial Manager

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.

Requirements:

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

Reports to:

Sr. Director of Clinical Affairs