Clinical Database Builder

Company
Synteract
Location
South Africa
Salary
Competitive
Posted
07 Apr 2021
Closes
07 May 2021
Ref
28688
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Clinical Database Builder - Bloemfontein

Who We Are

Synteract ® , a Syneos Health ® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies. We provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

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.


If you're passionate about bringing clinical trials to life, we encourage you to apply today!

Synteract's policy is to provide equal employment opportunity and affirmative action in all of its employment practices without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, individuals with disabilities, sexual orientation or gender identity or expression or any other legally protected category. Candidates must possess current and valid authorization to work in the country to which they are applying.

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