Requirements: English
Company: Actiris
Region: Antwerpen , Vlaams Gewest
Beschrijving van de functie At SGS, you can choose.First of all, out of our various vacancies. However, SGS also givesyou another choice. Do you choose to expand or to enrich? We arenot only looking for colleagues who can go into depths of theirdiscipline. We are equally as much looking for colleagues who wecall ''connectors'', people who can connect our diversity to ourservices. To each other. And this way, enrich our business. SGS isthe world''s leading inspection, verification, testing andcertification company. We''re also the benchmark worldwide forquality and integrity. And that makes us very proud. This can onlyhappen thanks to almost 100 000 colleagues worldwide, with morethan 1650 employees in Belgium only. Our employees give 110% ofthemselves every day, divided over all expertises, branches andcultures. Our coworkers build their own way inside the company, theservices and the expertise. SGS Pharma carries out all type ofservices for pharmaceutical and biotechnology companies, fromcoordination and running of clinical trials with new molecules ortechniques on human beings, to support and consultancy on postmarketing registration activities. Grow in a company that is thehome of global knowledge and expertise; that operates in a widerange of countries, services and sectors; and that offers youendless opportunities to learn, grow and fulfill you potential! Inthe spirit of continued growth, we are currently looking for aClinical Data Manager! In this role you act as the Data ManagementLead, overall responsible for the Data Management (DM) activitieson your clinical trial and you are the DM contact for allstakeholders. You are working together with the Data Programmer forthe set-up of the clinical data management systems (CDMS) in whichall data of your trial will be loaded and processed. You areresponsible for the delivery of clean, consistent, complete,submittable and reliable clinical trial datasets to the statisticalteam, the client and other parties. You keep the client up to dateon the status and progress of the trial with regards to DataManagement. This includes (but is not limited to) following tasks:Review of the Data Collection Tool (EDC Tool or eSource Tool)Creation of the Data Management Plan Communication with allinvolved stakeholders (client, external data vendors, clinical andbiometrics trial teams, medical monitors, sites) Defining andvalidating the programmed cleaning rules in the Data ValidationPlan Creation and validation of Data Transfer Agreements with allexternal data vendors (Central Labs, ECG provider, ePRO, .)Validation of the clinical SDTM database based on the applicableregulation standards Data cleaning through review of the rulesoutput Query handling to the sites/investigators Reconciliation oflaboratory and other external vendor data Coding of medications andmedical events Serious Adverse Event reconciliation Define anddetect Protocol Deviations Jouw profiel Master / PhD in BiomedicalSciences, Epidemiology, Pharmaceutical Sciences, Biology,Biomedical Engineering . Fluent in English and a proficientknowledge of Dutch Interest in working with data(bases) Likes tosolve problems! Accurate mindset Dedicated and persistent Goodcommunication skills Stress resistant Well-organized A real teamplayer Taalvaardigheden - Nederlands (troef) - Begrijpen : Vaardig- (C1) - Schrijven : Vaardig - (C1) - Lezen : Vaardig - (C1) -Spreken : Vaardig - (C1)