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Senior Clinical Research Associate - Belgium  

Company managed [?] Still accepting applications

Posted on : 22 December 2017

Project Description

Organization

Local affiliate of an International Medical Device Company

Description of the Position

Preparation of Clinical Trials
• Site assessments preparation of the materials for clinical trials (Investigational plan, Investigators brochure, Patients information,...)
• Preparation of files for the submission to Ethical committee, Competent Authority and other bodies if needed
• Preparation and management of Clinical trial documentation
• Follow-up of agreements with hospitals and investigators
• Technical preparation of Investigators and Steering Meetings
• Check the status of patient enrolment and milestone follow-ups in hospitals and feedback the status to investigators and study management periodically
• Clinical trials monitoring
• Provide assistance to global Clinical and Regulatory personnel
• Assistance in audit preparation

Regulatory
• Be compliant with the regulations related to the conduct of Clinical Trials according to international guidelines, local regulations and center specific requirements

Clinical Trial Monitoring
• Perform feasibility visits
• Perform site initiation, FUP and close-out visits
• Source data verification on-line and on-site
• Verification of inconsistencies on the case report forms
• Source documentation request
• Data cleaning (including but not limited to queries formulation and resolution)
• Preparation of presentations
• Preparation of Newsletters

General
• Follow the Internal SOPs
• Act as a representative of the company.
• Monthly reporting to management.

Demands of the Position

Your profile
• Master Life-science degree or equivalent by experience
• Experience in Clinical trials
• Experience in Oncology, Cardiology and/or Peripheral Endovascular Diseases are an asset
• Experience in medical devices is an asset
• Must be able to work in an international environment
• Fluent in English and preferably one other language
• Ability to function in a self-directed manner with a high degree of independence

Terms of Employment

Why The Clinical Company: We provide competitive salaries, comprehensive benefits packages and the support and training available to take the next step in your career and the opportunity to be of added value for the local and solid team of an International Medical Device Company.
Interested in this challenge and want to apply directly?! Please use the apply button below. For more information, feel free to contact Simone Polman at 0031 (0)612 996 359 or simone.polman@theclinicalcompany.com.