Senior Clinical Data Manager

Senior Clinical Data Manager

CROMSOURCE

Aachen, Germany

Main Job Tasks and Responsibilities

  • Performing data management project duties (project set-up, project planning, project review and reporting, project coordination and mentoring) to ensure appropriate quality of data management deliverables within agreed timelines and with control over the available budget;
  • Writing and/or reviewing the Data Management specific study documents (e.g. Data Management Plan, Data Validation Plan, Data Handling Specifications for 3rd party vendors providing external data) to describe and define data management activities and procedures that must be followed in order to meet the requirements of the study;
  • Taking full responsibility for all in-house data management processes, including in-house review, data coding, data entry, discrepancy management, data validation in clinical trials to ensure appropriate quality of data management deliverables within agreed timelines within the assigned studies;
  • Performing the eCRF design and creation of the annotated CRF under consideration of the SDTM standards;
  • Program or supervise the setup of the clinical trial database and the adjacent data validation routines within the clinical data management system (CDMS);
  • Programming data listings and complex validation checks in SAS and /or PL/SQL;
  • Perform project related communication with all internal and external parties;
  • Performing consultancy for clients with respect to Data Management processes to allow for smooth conduct of the project;
  • Liaise with internal business units as needed in the study conduct;
  • Performing data management trainings or presentations for internal/external clients ensuring their high scientific level;
  • Attend(blind) Data Review Meetings in order to provide professional support in data management related matters;
  • Attend bid defense meetings with clients to provide professional support in CDS related matters;
  • Plan and conduct client meetings as required in the project content.

Education and Experience

  • Higher education in sciences, medical or paramedical sciences, medical information specialist or other equivalent scientific training;
  • Excellent knowledge of data management and the relevant knowledge of guidelines for the conduct of clinical trials and medical investigations (e.g. ICH-GCP, EN ISO 14155);
  • Excellent knowledge in the conduct of EDC trials preferably with TrialMaster, Rave, Oracle Clinical RDC or other EDC tools;
  • Good programming knowledge of SAS and SQL;
  • Significant practical experience in data management within the conduct of all stages of a clinical trial;
  • Ability to work within tight deadlines and manage time effectively;
  • Fluent in English written and verbal communication. 

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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