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Clinical Data Specialist

Posted On:  09-Aug-2019
Job Category:  Clinical & Medical

At Terumo, we enhance lifesaving medical technologies for the benefit of society. Are you eager to contribute to people's health and patients' wellbeing? We'll challenge you to become a master in your field of expertise. You can invest your talents in balance with your personal aspirations - live and work in harmony. Built on our Japanese origins; we are driven by respect, ownership and continuous improvement. It is at the heart of everything we do. This is how we make a difference in the lives of patients, customers and associates.

Department Info

The EMEA Medical and Clinical Department (EMCD) provides best in class quality service in clinical, medical and scientific activities. They lead initiatives for faster product development and innovation by organizing and conducting clinical studies, presenting evidence of safety and efficacy of Terumo products and publishing scientific articles.

Job Responsibilities

1. Clinical data management:

  • You'll perform ongoing data cleaning and reviews to assure quality of the data and compliance with SOPs, GCP and ICH Guidelines.
  • You'll assist in eCRF development, 
  • You’ll edit checks and UAT of clinical studies.
  • You'll create and deliver study-specific site training.
  • You'll partner with clinical operations personnel to manage the query lifecycle.
  • You'll be responsible for handling all pre and post production service requests.
  • You'll assist PDM while developing and maintaining data management processes in compliance with Standard Operating Procedures (SOP).  

 

2. Preparation and conduct of Clinical Trials:

  • You'll ensure accuracy of clinical data through review of CRFs for completeness and consistency.
  • You'll provide clinical data export or reports to clinical operations team.
  • You'll partner with external service providers to support department goals. 

 

3. Regulatory issues:

  • You'll closely follow the regulations related to conduct of clinical trials in different countries.
  • You'll assist in updating DM processes to any change in regulation.
  • You'll assist in SOP preparation and update.

 

4. General:

  • You'll act as representative of the company.
  • You'll assume all other responsibilities and authorities this function may require regarding new opportunities.
  • General monthly reporting to Program data manager and divisional manager is also one of your responsabilities.
Profile Description
  • You have a Bachelor’s or Master’s degree in Bio-medical / Pharma / Life science / Informatica.
  • You have industrial experience of about 3-5 years in data management for clinical trial.
  • You have good knowledge of MS Excel, Access and PowerPoint.
  • You're experienced with EDC systems.
  • You're a team player, who's able to work in an international environment.
  • You are fluent in English.
  • You are able to motivate in a dynamic environment.   
Offer

We offer you a full-time position as a Clinical Data Specialist within a medical devices company. 

We offer you a marked based salary with additional benefits.   

Contact Person

Interested? Please send your CV + motivational letter in English to Bethsabee Bellinck - bethsabee.bellinck@terumo-europe.com

Terumo Europe is a core player in the EMEA healthcare market. We are a strong actor of the Terumo Corporation (Japan), producing, distributing, marketing and selling a vast range of medical devices. Terumo Europe EMEA headquarters and production facilities are located in Leuven (Belgium) with sales and marketing offices across the EMEA region.

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