Database Developer
Premier Research
Warsaw, Poland
9 d. temu

Description

Position at Premier Research Group Limited

RESPONSIBILITIES :

  • Creates electronic Case Report Forms (eCRFs) according to finalized protocols for EDC studies
  • Creates data entry screens according to the approved annotated Case Report Form (CRF) for paper studies
  • Designs, builds and tests clinical databases according to Premier Research standard operating procedures
  • Programs field derivations, edit / consistency checks, and setup of screen flow in the CDMS for Data Entry
  • Works in collaboration with the Data Management project team, Statistician, Project Manager and the sponsor to define all elements of the data management plan
  • Writes procedures, validation and data extraction programs
  • Produces database documentation including an annotated CRF
  • Ensures database documentation is maintained for the Trial Master File
  • Works in collaboration with the Data Management project team, Statistician, Project Manager and the sponsor to define all technical elements of the data management plan
  • Performs system testing and assists with Quality Control (QC) of specified deliverables
  • May assist in maintaining the CDMS global and program libraries
  • May be required to undertake programming tasks
  • All other projects as assigned
  • EDUCATION, SKILLS & COMPETENCIES :

    Educational Background

  • Educated to Bachelor’s degree level, or equivalent. In lieu of this qualification, 3 years of experience in clinical research, drug development or healthcare environment will be required
  • Experience

  • 12 months of clinical database development experience required. Alternatively, must have proven experience in all primary job functions.
  • Prior experience using computerised information systems preferred.
  • Ability to read, write, and speak fluent English; fluent in host country language.
  • Clinical trials support or pharmaceutical industry experience preferred.
  • Office based or clinical employment experience preferred.
  • Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
  • Expertise and know-how

  • Has developed understanding of database development processes, SOPs, and working guidelines.
  • Knowledge of ICH / GCP regulations
  • Working knowledge of FDA Guidance Documents / EU Directives / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Knowledge of web based communication tools for conferences
  • Personal skills & behaviours
  • Fluent verbal and written English as well as the local language(s) required for clinical trial submissions.
  • Excellent team player, collaborative and able to build an effective team.
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities.
  • Strong verbal and written communication and negotiation skills.
  • Excellent organisational and time-management skills, able prioritise work to meet deadlines.
  • Accountable, dependable and strong commitment.
  • Is customer service focused in approach to work both internally and externally.
  • Maintains a positive, results orientated work environment.
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