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Precision Medicine Group

Principal Database Programmer

RemoteEU
Published
Role
Data Engineering
Experience
Principal
Employment
Full-time
Salary not disclosed
Check eligibility

Open to Anywhere in EU. Set where you work from to check your eligibility.

No BS summary

Principal-level clinical database programmer with 8+ years' experience. Must have strong Medidata Rave and Veeva experience, CDISC knowledge (CDASH/SDTM/ADaM) and object‑oriented programming (C#, C++, VBScript). Remote within Europe required; full-time, permanent role leading database programming and operational study teams.

Core skills

Medidata RaveVeeva

Required skills

C#C++VBScriptCDISC (CDASH, SDTM, ADaM)Microsoft WordMicrosoft ExcelMicrosoft PowerPointMicrosoft OutlookClinical database management system development

Optional languages

English Professional (written and oral)"""Professional"""

What you'll do

  • Maintains responsibility of assigned projects and ensures on-time delivery.
  • Communicates project status to internal teams and study teams.
  • Maintains awareness of contract key elements and scope of work for assigned projects.
  • Performs project forecasting of hours, identifies resource requirements and manages project budgets including out-of-scope work and post production changes.
  • Provides input and guidance to the design of clinical databases to clients and internal teams.
  • Builds and supports clinical databases.
  • Develops, tests, and validates programs and clinical databases to support client-related projects and third-party applications.
  • Provides system administration and advanced technical support services for internally developed applications and clinical databases, client-related projects and third-party applications.
  • Troubleshoots and resolves software and clinical database problems.
  • Develops and maintains study-specific validation documents.
  • Provides support to data management from CRF design to post database close and archival.
  • May design, develop and validate the Company’s internal applications, client-related projects and third-party applications.
  • Participates in software vendor selection, EDC demonstrations and trainings.
  • Participates in development and maintenance of SOPs and process documentation related to data and database management activities.
  • Supports onboarding of new hires and provides operational and technical training to end users and junior staff.
  • Provides leadership for cross-functional and organization-wide initiatives where applicable.
  • Trains and ensures data management project team members have been sufficiently trained.
  • Communicates with study sponsors, vendors and project teams regarding data, database or other relevant project issues.
  • Presents software demonstrations/trainings and participates in project meetings.
  • Performs all duties in accordance with SOPs, government regulations, guidelines and industry standards.
  • May require some travel.
  • Performs other duties as assigned.

What they require

  • Minimum 8 years’ experience.
  • Bachelors and/or a combination of related experience.
  • Strong experience in Oncology; experience with Autoimmune diseases is a strong advantage.
  • Strong experience with Rave and Veeva.
  • Proficiency in Microsoft Office: Word, Excel, PowerPoint, Outlook.
  • Experience in Object Oriented Programming (C#, C++, VBS, etc.).
  • Understanding of CDISC standards (CDASH, SDTM, ADaM, etc.).
  • Proficiency in more than one CDMS system to include building forms, edit checks and complex rule development.
  • Awareness of CRF standards and input to maintenance of standards library.
  • Ability to troubleshoot and support peers with technical issues and build solutions.
  • Broad knowledge of drug, device and/or biologic development and effective data management practices.
  • Able to handle a variety of clinical research tasks.
  • Experience in clinical database management system development.
  • Experience in a clinical, scientific or healthcare discipline.
  • Professional use of the English language; both written and oral.
  • Strong leadership and interpersonal skills.
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What people say about this company

3.3/ 5

Details

Posting languageEnglish
Salary not disclosed