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Clinical Data Specialist

Introduction


The objectives of the European 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.


Company/Department


medical devices company, the clinical and medical department


Function information


 Clinical data management

Performs ongoing data cleaning and reviews to assure quality of the data and compliance with SOPs, GCP and ICH Guidelines

Assist in eCRF development, Edit checks and UAT of clinical studies

Creates and delivers study-specific site training.

Partner with clinical operations personnel to manage the query lifecycle

Responsible for handling all pre and post production service requests

Assist PDM while developing and maintaining data management processes in compliance with Standard Operating Procedures (SOP)

Preparation and conduct of Clinical Trials

Ensure accuracy of clinical data through review of CRFs for completeness and consistency

Provide clinical data export or reports to clinical operations team

Partner with external service providers to support department goals

Regulatory issues

Closely follow the regulations related to conduct of clinical trials in different countries

Assist in updating DM processes to any change in regulation

Assist in SOP preparation and update

General.

Act as representative of the company.

Assume all other responsibilities and authorities this function may require regarding new opportunities.

General monthly reporting to Program data manager and divisional manager

 


Requirements


  • Bachelor’s or Master’s degree in Bio-medical / Pharma / Life science / Informatics
  • Industrial experience of about 3-5 years in data management for clinical trial
  • Experience in Medical devices (Oncology, Cardiology) is an advantage
  • Good knowledge of MS Excel, Access and PowerPoint
  • Experience with EDC systems (Preferably Openclinica, Merge & Genae systems)
  • Team player, able to work in an international environment
  • Fluent in English
  • Ability to motivate in a dynamic environment
  • High personal integrity

Offer


Fix contract with interesting advantages


Information


Sandra Rizzuto

sandra.rizzuto@xpe-group.com


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