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Senior Data Manager - Italy  

OPIS (company)


Posted on : 08 March 2017

Project 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 Requirements 
  • 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 skills to respect strict deadlines