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Clinical Applications SME

Antwerpen, Antwerpen

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Position: Clinical Applications SME for Digital Technology (DT) Clinical Analytics

  • Start Date: July 2026
  • End Date: July 2027
  • Location: Remote EU time zone (No CVs from UK or Germany)

Responsibilities:

  • Manage and support clinical applications (GxP and non-GxP systems).
  • Maintain and operate clinical data analysis platforms, including R Shiny apps and dashboards.
  • Handle system updates, changes, and releases.
  • Support validation activities with IT Compliance and QA teams.
  • Manage user access and incidents.
  • Coordinate testing, training, and acceptance activities.
  • Lead or contribute to DT projects, including planning, reporting, and communication.
  • Collaborate daily with cross-functional stakeholders and external vendors.

Required Qualifications and Experience:

  • Proven experience in IT and project management.
  • Strong experience in clinical development / Pharma IT environments (senior-level profile expected).
  • Minimum 2-3 years of experience.
  • Strong relevant professional background.
  • Experience in GxP environments and regulatory standards (GAMP5, V-model, 21 CFR Part 11, Data Integrity).
  • Experience in clinical development systems / Health IT.
  • Solid project management experience, including PMO activities.
  • Ability to work in complex, cross-functional, and matrix organizations.
  • Fluent in English.

Desired Skills and Certifications:

  • Strong mix of technical expertise and project leadership.
  • Hands-on experience with clinical analytics tools and platforms.
  • Autonomous, proactive, and solution-oriented mindset.
  • Effective in a fast-paced and international environment.
  • Strong communication and stakeholder management skills.
  • Experience with R Shiny applications and frameworks.
  • Experience with Power BI dashboards.
  • Knowledge of Agile / SCRUM methodologies.
  • Additional languages (French or Dutch) are a plus but not required.
  • Certifications are not mandatory.

Language Proficiency:

  • English: Mandatory (working language)
  • French/Dutch: Not required (nice to have only)

Homeworking Policy:

  • Can be remote EU time zone, NO CVs from UK or Germany

Work Schedule:

  • Full Time: 100% or 90% (to be discussed)

Interview Process:

  • Conducted via Microsoft Teams
  • 1 to 2 interview rounds, depending on the candidate
  • Recruitment timeline: approximately 1 month to identify the selected candidate