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Randomisation Officer Mechelen Belgium,  

Posted on : 11 April 2017

Project Description

SGS is the world s leading inspection, verification, testing and certification company. The company employs over 85 000 people and operates a network of more than 1 000 offices and laboratories around the world. In Belgium 1.650 people are working for SGS. One of the business segments, Life Science Services, is a leading contract research organization (CRO) offering Clinical Research Services to the pharmaceutical and biopharmaceutical industry. At the Secure Data Office, we handle all data that is unblinding in nature, pharmacokinetic concentrations, pharmacodynamic data, immunogenicity data, etc  We receive data from the bio-analytical labs and combine this with the patient data captured at the clinical sites. These data is converted by us into the standard file format. We are the turntable between the labs, the data management companies and the pharmaceutical companies. We are currently seeking candidates for the following position (m/f) : Randomisation Officer (Mechelen) Tasks: The Randomisation Officer will be responsible for the transfer of unblinding data from and to the Secure Data Office and the cleaning of unblinding data within the Secure Data Office. These responsibilities encompass the creation of data transfer agreements, data cleaning documentation and the specification of edit checks and listings. The Randomisation Officer also performs the QC of unblinding data, the cleaning of the data in EDC and/or clinical database and the creation/follow-up of edit checks. In addition to the above mentioned activities, the Randomisation Officer will also be responsible for the handling of randomisation lists (upload of randomisation list in internal IWRS system, release of randomisation list at database lock, emergency unblindings, distribution of randomisation list to third parties, &) Liaise with clients and external service providers Organize and lead kick-off meetings and teleconferences with the clients Discuss specifications about the lab data and the patient data we receive and the expected format that we are delivering Creation of Data Transfer Agreements for external data Support in Quality control Actively contribute to process improvement " Master or PhD degree in sciences or relevant experience " good knowledge of English " eye for detail, very accurate " quality minded " flexible " communicative " positive, constructive, professional attitude towards colleagues, team members and clients " time management skills " stress resistant Interested? Do you know somebody who might be interested? Please submit your application online Should you have questions: LinkedIn #LI-HA1


Belgium Vlaanderen Mechelen

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