Onsite Data Transfer Lead

Arbetsbeskrivning

Proffice is, on assignment of one of our customers, looking for a Data Transferer. Our customer is a global company which recently based in Sweden. Job Description . Provide expert review and guidance for production of Data Management deliverables including CRF/e-CRF, database design and set-up, validation definition and programming, Data Management Plan and database deliverables to internal and external customers. . Provide technical advice and solutions with internal and external customers to solve problems and improve efficiency . Ensure compliance of work with project's scope of work . Understanding Change in Protocols for ongoing studies and coordinating with offshore team with requirements . Co-ordination of user acceptance testing and change control of new system versions . Designing & reviewing specs for external data Vendors . Setting up and maintaining contracts with 3rd party vendors along with providing transfer and load specifications . Review of data transfer reports and maintenance of necessary documentation . Provide specification document from protocol for the 3rd party vendor and training for site investigators . Successfully led and project managed key data management activities related to regulatory submission . Managing issues, escalating, coordinating with Study team, bio-statisticians, Data managers and other interfaces as appropriate. Qualification . A degree in clinical, biological or mathematical sciences or related field, or nursing qualification with 7+ years of relevant work experience in the clinical data management field. . Strong understanding of clinical trial methodology, Good Clinical Practice (GCP) and medical terminology . Must have advanced knowledge of the clinical data management processes and systems . Experience in vendor management and specification preparation for 3rd party systems for IVRS and lab data . Outstanding written and oral communication skills are required . Substantial people management experience. . Excellent organizational skills and demonstrated ability to delegate appropriately. Experience in effectively managing multiple tasks simultaneously.

Sammanfattning

  • Arbetsplats: Gothenburg
  • 1 plats
  • Heltid
  • Publicerat: 25 september 2007
  • Ansök senast: 25 oktober 2007

Postadress

Gothenburg
GÖTEBORG, 40530

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