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CDISC conversion

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Note: This employment opportunity has expired and is no longer available. It has been retained for historical interest only.
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About TAKE Solutions

Join a rapidly growing global company genuinely committed to improving IT solutions in the Life Science arena.

TAKE Solutions is a leading international technology company with products and services in Life Sciences & Supply Chain Management. With almost 500 current employees, TAKE Solutions Global Life Sciences headquarters are in Princeton, N.J., USA.

TAKE Solutions is looking for experienced individuals in all facets of life sciences, with numerous immediate openings around Clinical Life Cycle Data Management and in the standardization of Clinical Data using the CDISC SDTM.

CDISC Analyst

The successful candidate will have substantial knowledge and experience with clinical data specifically around CDISC SDTM standards.

Overview: The appropriate Individuals will provide primary support study standardization to the CDISC SDTM by creating the SDTM design specifications, including the Annotated CRF and the specification documents. You will oversee execution of the specification by the SDTM standardization specialists, as well as help manage the SDTM design specification life-cycle. You will work closely with the Senior CDISC Analyst, the SDTM project managers, as the primary interface with clients during the standardization projects.

Qualifications:

  • A Bachelors degree in the medical/technical field or relevant work experience
  • 2-4 years of experience working in pharmaceutical or CRO, specifically in Clinical Data Management or Biostatistics
  • Strong knowledge of CDISC SDTM model
  • Impeccable verbal and written communication skills
  • Ability to adapt to a constantly progressing industry

Technical qualifications:

  • A minimum of 1 years experience in CDISC conversion
  • Strong technical knowledge of CDISC SDTM model
  • Clinical Data Management experience
  • Extensive Microsoft Office experience

Key Responsibilities:

  • Work with Senior staff to oversee the CDISC SDTM Standardization/Analysis process
  • Development of CDISC SDTM mapping specifications
  • Creation of data definition files and Case Report Forms annotated to CDISC SDTM
  • Ability to meet last minute and scheduled deadlines
  • Develop and manage SOPS and guidelines

Please contact me for immediate consideration

Wayne Howell Resource Manager TAKE Solutions 609-720-1002x242 wayne.howell@takesolutions.com