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Global Clinical System Coordinator

Job description

Department Info

The objectives of the EMEA Medical and Clinical Division are to organize, manage and conduct clinical trials by respecting all regulatory requirements and Good Clinical practice, to communicate clinical data to wider audience, to manage all medical aspects of company products, and to contribute to the new products and new therapies development.

Job Summary

In this new and exciting position, you will be coordinating the global role out of one clinical system across several companies.  You will pioneer on the EMEA HQ, and later support the role out in US, UK and Japan. You will be responsible for system validation and general system management and updates. This role reports to our Group Manager Clinical Data Sciences & Systems in EMEA.

Job Responsibilities

  1. Clinical IT Systems

As a good project manager, you are responsible for project setup & maintenance of system libraries

You are responsible for the identification and implementation of database improvements based on user feedback and new business processes. You verify software deployment, upgrades and assist with system validation.

To ensure a smooth transition, you test and execute User Acceptance Test scripts, review System Test scripts and if required take care of data migration from other applications. 

You create study dashboards, reports and ensure data integrity checks. You oversee Business administration

In addition, you are responsible for providing business process support, as extension of the helpdesk and in partnership with the global business process owners.

You interact on a regular basis with global business leaders, local business administrators and external vendor(s).

  1. Clinical Trail Management System (CTMS) and Electronic Data Capture (EDC)

To enhance efficiency on the management & follow-up of our clinical investigations you ensure consistent and accurate data flow within and among all the clinical systems.  You provide application support to the study team. 

  1. Electronic Trial Master File (eTMF)

You Prepare for and support during audits and regulatory authority inspections relating to the use of the system

You identify and report any quality or compliance concerns and take immediate corrective action as required. Furthermore, you are responsible for updating processes to any change in regulation

Profile Description

You have a bachelor’s or master’s degree in Informatics/ Computers/ Bio-medical and can look back to 5 years professional working experience.  Medical devices experience is an advantage.

Experience working with CTMS, eTMF and EDC/CDMS systems is key in this role.  You are proficient in Systems Development Life Cycle principles and databases.  You have a good knowledge of GCP/ICH guidelines.

You are an excellent communicator, you build bridges, solve problems, and can work well in a multicultural team to reach results.  You are fluent in English

In addition, you have excellent project management skills and a proven track record in delivering projects within timeline.

Furthermore, you are able to shift priorities in line with the business updates and adapt the implementation plan accordingly.

Contract

Executive search

Experience

minimum 5 years

Education

Higher Education

Languages

English

Sector

Medical Devices

Region

Leuven

Job type

Full-time

 
 

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