Clinical Applications Specialist – Clinical Analytics & GxP Compliance
Digital
Development
Master
Advanced (5+)
- Emplacement
- Braine-l'Alleud, Brabant wallon
- Type de travail
- Consultancy
- Modèle de travail
- 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.
Responsabilités
- 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.
Exigences
- 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.
Offre
- 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
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