Clinical Site Manager, Field

Element Science

New York City, NY, US
  • Job Type: Full-Time
  • Function: Clinical Research
  • Post Date: 04/02/2021
  • Website: elementscience.com
  • Company Address: 200 Kansas Street Suite 210, San Francisco, CA, 94103

About Element Science

Element Science is a San-Francisco based medical device and digital health start-up that develops lifesaving wearable solutions designed to deliver an outstanding experience. By putting the patient first, we seek to redefine what lifesaving medical devices can be. Our approach is founded on combining user-centric design, a rigorous approach to medical device development, and the integration and application of data science and machine learning. Our focus is on developing solutions that address leading causes of death and hospitalization due to heart disease.

Job Description

We are seeking a regionally-based Clinical Site Manager, Field to join our growing medical technology company. Working closely with the in-house Sponsor clinical team, these individuals will be responsible for training the sites and each patient on the clinical trial and the technology, in support of the US IDE clinical trial for our flagship product. The CSM will be the local Sponsor representative for all clinical sites, serving as a local expert and logistical troubleshooter. The ideal candidate will have experience with IDE studies of Class III medical devices, excellent people skills, the ability to thrive in a fast-paced environment, and a can-do attitude as well as a passion for working on a cutting-edge, life-saving product.

Responsibilities:

  • Train the physicians and site personnel on the study devices, follow up requirements, and all aspects of the clinical trial
  • Train all potential patients who are being screened for the clinical trial.
  • Serve as the local expert on the product and trial; serve as the key point of contact for the study sites in the assigned region, referring questions to the In-House team as appropriate
  • Work with the study sites to identify any barriers to enrollment; work with the In-House team as needed to resolve the barriers to meet enrollment goals and complete the trial in a timely manner
  • Develop strong and productive relationships with study personnel at the clinical sites
  • Monitor / co-monitor
  • Participate in and/or complete other activities as assigned

 

Qualifications:

  • Bachelor's degree in nursing, biomedical engineering, or related field preferred
  • Experience in cardiology required; IBHRE certification preferred
  • Minimum 5 years experience in clinical research in the medical device industry, including experience with Class III medical devices
  • Thorough understanding of FDA IDE regulations
  • Able to troubleshoot issues and think creatively under pressure
  • Excellent relationship management skills
  • Strong writing skills and exceptional attention to detail
  • Familiar with software databases: Electronic Data Capture systems, MS Office
  • Able to travel frequently, depending on coverage requirements, with occasionally overnight trips. Must have the flexibility to respond to emergent events within hours

Related Jobs

Sr. R&D Electrical Test Engineer

Element Science - San Francisco, CA, US

Test Engineering Manager

Element Science - San Francisco, CA, US

Sr. Software Quality Engineer - Firmware

Element Science - San Francisco, CA, US

Director, Systems Engineering

Element Science - San Francisco, CA, US

Director Mechanical Engineering

Element Science - San Francisco, CA, US
Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.