Senior Clinical Database Programmer
Parexel
Taiwan - Taipei - Taipei
6天前

Job Description

  • Lead and supervise and / or create, implement and execute procedures to build and maintain database set-up for paper based and / or web based (EDC) clinical data management systems (CDMS) in standard format or CDISC compliant format as required, including the annotation of CRFs where applicable.
  • Lead and supervise and / or create,, implement and maintain consistency checks in standard or CDISC format for database builds in CDMS and EDC, following and understanding internal and external regulatory requirements.
  • Accountable for first time quality on all deliverables
  • Provide feedback for study programmers on the creation of eCRF’s following SOPs and internal process guidelines
  • Provide input into and negotiate database setup timelines.
  • Ensure that timelines are adhered to by :
  • o Actively assume activities on a project as required.

    o Monitor project resourcing and identify changes in scope.

    o Assist project teams in the resolution of problems encountered in the conduct of their daily work to ensure first- time quality.

  • Interact with Sponsors and Data Management Leaders as the key contact with regard to programming related issues.
  • Provide technical support and advice to the internal team.
  • Ability to lead and support various programming activities related to clinical systems, and / or the applications / systems within eClinical technologies on multiple projects simultaneously.
  • Lock / Unlock databases in accordance with guidelines and SOPs. Approve changes made to databases (as required).
  • Assist in providing technical solutions to internal or external client enquires.
  • Develop wider knowledge of areas of Clinical Data Management Systems (CDMS), Electronic Data Capture (EDC), Clinical Trial Management System (CTMS), Safety Reporting and other programming language usage and processes within the GDO area.
  • System (CTMS), Safety Reporting and other programming language usage and processes within the GDO area.
  • Ensure adherence to service levels agreements with regard to the turnaround time from the point when specifications are finalized
  • Provide relevant training and mentorship to staff and project teams as appropriate.
  • Assist project teams in the resolution of problems encountered in the conduct of their daily work.
  • Assist in providing technical solutions to internal or external client enquires.
  • Maintain and expand local and international regulatory
  • Qualifications

  • English capability.
  • CRO or Pharm experience.
  • Rave experience.
  • Demonstrate strong organizational skills, ability to manage competing priorities, and be flexible to change.
  • Attention to detail.
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