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Dear Allstat,

Please find below our latest CONTRACT opportunity as a Data Integration Specialist.


International CRO
Clinical Data Manager - Data Integration Specialist
Belgium (Brussels)
6 months - renewable contract
Competitive hourly rate


FUNCTION DESCRIPTION:

The Clinical Data Manager - Data Integration Specialist is a key member of a multidisciplinary team involved in implementing CDISC data standards in clinical trials.
As such, you convert legacy (or on-ongoing) clinical study data and metadata into a CDISC format in order to comply with the Food and Drug administration (FDA) submission requirements, or prepare clinical data into a data warehouse ready format in order to maximize its usability.

RESPONSIBILITIES

  *   Content and structure analysis of the legacy data and the clinical trial protocol
  *   Annotation of Case Report Forms using CDISC Terminology
  *   Preparation of clinical data CDISC conversion definitions
  *   Development of project documentations (Data Reviewers Guide and Data Handling Report)
  *   Validation of the data and metadata according to the applicable CDISC standards and guidelines
  *   Quality Control of all project deliverables
  *   Responsibility for the timely delivery of a CDISC-compliant submission package
  *   Contribution to the definition of CDISC validation checks


MINIMUM REQUIREMENT

  *   Master's degree in scientific or healthcare discipline or equivalent through experience
  *   A minimum of 1 to 3 year(s) experience in a clinical trial environment
  *   Strong understanding of data management and database administration: clinical protocol assessment, Case Report Form design, understanding of clinical data management systems, study start up (database administration, edit check creation / validation) and data base lock.
  *   CDISC knowledge is a plus
  *   Good knowledge of ICH/GCP
  *   Basic SAS knowledge
  *   Good English written and oral communication skills
  *   Quick learner
  *   Excellent team player
  *   Able to plan work in order to meet deadlines


For a confidential consultation call Emel Kahraman on +44 203 465 0037 or email your CV to [log in to unmask]


I look forward to hearing from you

Kind regards




Emel Kahraman

Resourcing Consultant, Europe
Recruiting experts in Life Sciences

HAYS Recruiting experts worldwide
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London
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T:  +44 203 4650 0037
F:  +44 203 465  0001

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