Clinical Database Builder
Synteract
Bloemfontein, South Africa
5d ago

Who We Are

Synteract is a global full-service contract research organization with a successful three-decade track record supporting biotechnology, medical device and pharmaceutical companies.

With our mission of Bringing Clinical Trials to Life, we provide customized Phase I through IV services internationally, offering expertise across multiple therapeutic areas including notable depth in Oncology, Neuro Degenerative Diseases, and Rare and Orphan Diseases, and in pediatric populations.

Our mission is to support the innovation and development of better therapies in healthcare. Position Overview The Clinical Database Builder is responsible for Case Report Form (CRF) development and clinical study database build in accordance with the Clinical Data Management System (CDMS) guidelines and Synteract standards for CRF development and study build.

You'll ensures on-time delivery and communicates the status of projects to internal teams. Specific tasks would include :

  • Performs, or assists with, the validation of clinical study databases.
  • Provides support for user account administration for all in-house Clinical Data Management Systems (CDMS), including Medidata Rave or Marvin.
  • Implements and QC s efficient Electronic Data Capture (EDC) clinical databases; building forms (using Adobe Framemaker if a paper project or the CDMS) and fields per specifications provided by Data Managers.
  • Qualifications

  • Bachelor’s degree in a relevant field of study and 0-2 years related work experience inclusive of or equivalent combination of education, certification and experience.
  • Fundamental understanding of data management practices and clinical data management systems (CDMS).
  • Fundamental understanding of Clinical Trial processes, specifically as they are related to data collection and management.
  • Fundamental understanding of data capture / data reporting and industry standards such as SDTM and CDASH.
  • Fundamental understanding of 21CFR11, HIPAA and computerized systems validation.
  • Proficiency in Microsoft Office; Word, Excel, PowerPoint, Outlook as required.
  • Basic proficiency in graphic programs such as Adobe Framemaker and Adobe Acrobat.
  • Effective verbal and writing skills; English + local language, if relevant.
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