Clinical Research Associate (f/m/d)

Jena
Occlutech GmbH

Benefits

  • Arbeitsweg

  • Beruf und Familie

  • Essen und Trinken

  • Gesundheit

  • Vorsorgeleistungen

Occlutech is a leading specialist provider of minimally invasive cardiac devices, with a mission to improve the quality of life for people with heart conditions. The vision is to become a leading global specialist provider in cardiac devices, addressing congenital heart defects, stroke prevention, and heart failure.

Occlutech has a broad and proven portfolio, based on proprietary technology, and over 200 patents with more than 139,000 products sold. The company markets and sells its products in approximately 85 countries and has around 300 employees.

 

We are looking for a Validation Specialist in Jena, Germany.

 

The  Clinical Research Associate  ensures the overall quality of clinical trials by monitoring study data and managing site adherence to the protocol, all applicable regulations, and related study documents. The CRA is the primary contact with the study site and serves as the liaison between clinical investigators and the sponsor.

Your work will focus on

  • Planning, preparing, and managing all monitoring-related activities, the performance of monitoring of trial/registry sites

  • Conducting clinical trials, clinical studies, and registries according to all applicable regulations, commonly accepted practices, and to Occlutech's internal guidelines, ie

  • Prepare essential documents according to ISO 14155, MDR

  • Care for submission approvals by Competent Authorities and favorable opinions by responsible Ethics Committees

  • Plan and track the course of the studies and update tracking lists

  • Liaise with study investigators and site staff regularly

  • Oversee and lead subcontractors such as, but not limited to, data management, local monitors

  • Assisting in study audits

  • Communication between investigators/site staff and Occlutech

  • Providing regular updates to CRM on trial status, plans, and bottlenecks

  • Contributing to the Occlutech QM system

Your qualification

  • A Bachelor's and/or a Master's degree in science or health-related field

  • A minimum of 3 years of experience in the field of clinical research

  • Knowledge of relevant government regulations, standards, and guidelines

  • Knowledge of Medical Device Regulation (MDR)

  • Strong analytical and problem-solving skills & excellent interpersonal and communication skills & team player.

  • Proven track record of working in a dynamic, international environment

  • Proficient user of computer applications, and software for the execution of daily project operations

  • Experienced in using a Clinical trial management system (CTMS) or equivalent

  • Ability to travel when it is needed

  • Excellent written and spoken English and German knowledge.

  • Excellent written and verbal communication skills are required. Demonstrated proficiency with ICH, GCP, and ISO is required

Working Conditions:

  • The CRA position is a remote position requiring about 75% traveling.

Our company offers

  • Family corporate culture

  • A secure and multifaceted job in medical technology

  • Company pension plan

  • Fresh fruit and drinks

  • Flextime

  • Work-life balance

  • Regular company events

Does this spark your interest

If you enjoy working in a diverse, multicultural team we are looking for you to join our diverse team dedicated to improving the lives of patients.

 

Are you interested?
Please send your complete application documents (Letter of motivation, resume, references - all in one PDF file) including your salary requirements and the earliest possible start date.

 

For more information about our company, please visit us:

https://occlutech.com/

www.occlutech-jena.de

Benefits

  • Arbeitsweg

  • Beruf und Familie

  • Essen und Trinken

  • Gesundheit

  • Vorsorgeleistungen

Arbeitsort

Winzerlaer Str. 2, 07745 Jena

Mehr zum Job

Beschäftigungsart Festanstellung
Arbeitszeit Vollzeit
Arbeitsort
Winzerlaer Str. 2, 07745 Jena