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Clinical Applications Specialist – Clinical Analytics & GxP Compliance

Digital
Development
Master
Advanced (5+)
Locatie
Eigen-Brakel, Waals-Brabant
Type werk
Consultancy
Werkmodel
Fulltime, Hybrid

Our client, a leading organization in the pharmaceutical sector, is looking for a Clinical Applications Specialist to join the clinical development team. This position involves implementing, maintaining, and ensuring the compliance of technology solutions used in clinical analytics within a highly regulated environment.

Verantwoordelijkheden

  • Manage and support clinical applications across both GxP and non-GxP systems.
  • Maintain clinical data analysis platforms, including R Shiny applications and dashboards.
  • Handle system updates, changes, and releases to ensure operational continuity.
  • Support validation activities in collaboration with IT Compliance and Quality Assurance teams.
  • Manage user access and incidents while coordinating testing and training activities.
  • Lead or contribute to digital technology projects, including planning, reporting, and communication.
  • Collaborate daily with cross-functional stakeholders and external vendors to drive project success.

Vereisten

  • 3+ years of experience in IT and project management within clinical development or pharmaceutical environments.
  • You possess strong knowledge of GxP regulatory standards, including GAMP5, V-model, 21 CFR Part 11, and Data Integrity.
  • You have experience managing clinical development systems and health IT solutions.
  • You bring a solid background in project management and PMO activities within matrix organizations.
  • You're experienced in managing technical application lifecycles and stakeholder expectations.
  • You possess a proactive and solution-oriented mindset.
  • You are fluent in English.

Nice to Haves

  • Experience with R Shiny applications and frameworks.
  • Proficiency in creating Power BI dashboards.
  • Knowledge of Agile or Scrum methodologies.
  • Knowledge of French or Dutch.

Aanbod

  • Start date: July 2026
  • Duration: 12 months
  • Work regime: Full-time (90% or 100%)
  • Location: Remote
  • Working model: Remote (EU time zone); VDI only (no hardware provided)
  • Contract: open to both permanent employees and freelancers
# 101545
Met een plusteken en landcode (bijv. +32 400 00 00 00).
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Kandidaten moeten wettelijk gerechtigd zijn om in de EU te werken en over de vereiste taalvaardigheden voor de joblocatie beschikken.
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