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Principal Clinical Programmer

Company: ProPharma Group
Location: Deerfield
Posted on: June 22, 2022

Job Description:

Company DescriptionProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.Job DescriptionSmart, hard working and friendly team (aka family); opportunities for growth and development; flexible hours and fully remote work

  • Design, develop, implement, maintain,and support clinical database systems.
  • Offer technical expertise for internal and external clients.
  • Code, test,and document databases as per programming standards and clinical validation policies.
  • Program database manipulation and conduct data transfers for clients.
  • Review Data Validation Plans and Case Report Forms as per area of expertise.
  • Add all external data sources such as PK and central lab within the clinical database if integration is requested or required.
  • Serve as programming contact to handle database issues within area of expertise.
  • Support development and implementation of new technologies.
  • Support Information Technology to evaluate new technology upgradesby participating in software change controls.
  • Support development, revision and maintenance of core operating procedures and working instructionspertaining to database development, user acceptance testing and change controls
  • Interface with project team to organize responsibilities and deliverables.
  • Establish effective communication and professional relationships with teams and external vendors.
  • Interface with Clinical Data Management and corporate team to negotiate timelines.
  • Perform administrative tasks within the EDC system, such as site and user management, URL level reviews and/or approvals, and dictionary updates.
  • Follow and influence the development of data standards and strategies pertaining to the standards libraryQualifications
    • Minimum BS in a scientific or health related field or equivalent in years of experience.
    • Minimum 3 years of experience as a clinical database developer with at least 5 years of experience leading a study build.
    • Experience with EDC systems, preferably with ICD and Rave
    • Understanding of the principles of ICH GCP and regulatory requirements is essential.
    • Excellent organizational and analytical skills, strong oral and written communication skills, and able to work in a high paced, timeline driven setting.Additional InformationAll your information will be kept confidential according to EEO guidelines.

Keywords: ProPharma Group, Arlington Heights , Principal Clinical Programmer, IT / Software / Systems , Deerfield, Illinois

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