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Senior Data Manager Desio Italy,  


Posted on : 08 March 2017

Project Description

Location Desio (MB), Italy Job Description Job Description The Senior Data Manager, under the supervision of the Head of Data Management Unit, is in charge of the following activities: Design the paper or electronic Case Report Forms (CRF), including paper PROs (diaries, questionnaires), in co-operation with the Sponsor, Project Manager, Statistician and ICT staff Prepare/review the data management documents (e.g. Data Management Plan, Data Validation Plan, eCRF Completion Guidelines, Protocol Deviation Handling Document, etc.) Prepare and validate the eCRF/clinical databases and related tools Define the requirements and validate the IVRS tool Organize/perform trainings for project team Coordinate/perform data cleaning activities Organize data entry activities, when needed Perform coding activities of medications and medical terms using medical dictionaries Perform SAE reconciliation when required Define the requirements to handle external clinical data and prepare the Data Specifications Document, and perform import and reconciliation of external clinical data Perform database lock Prepare, maintain, and archive data management documentation Perform quality control according to the Data Management Plan Liaise with Sponsor and third parties with regard to data management activities Track activities and milestones to ensure timely project deliverables Collaborate in establishing and maintaining SOPs related to Data Management Collaborate in establishing and maintaining document/programming standards Contribute to on-boarding of new associates and act as a mentor for junior staff   Job Requiements Scientific degree At least 5 years of experience in a Pharmaceutical company or CRO Excellent knowledge of SAS programming language Fluent in English Good communication skills and team work Good time management

Locations

Desio (MB) Italy

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