Clinical Applications SME – Digital Technology, Clinical Analytics

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee and provide support for clinical applications, encompassing both GxP and non-GxP systems.

• Sustain and operate clinical data analysis platforms, which include R Shiny apps and dashboards.

• Manage system updates, modifications, and releases.

• Assist in validation activities alongside IT Compliance and QA teams.

• Administer user access and address incidents.

• Coordinate testing, training, and acceptance processes.

• Lead or participate in Digital Technology projects, covering planning, reporting, and communication aspects.

• Engage daily with cross-functional stakeholders and external vendors.

⛳️ Requirements

• Demonstrated experience in IT and project management.

• Extensive experience in clinical development or Pharma IT settings.

• Strong and relevant professional background.

• Familiarity with GxP environments and regulatory standards, including GAMP5, V-model, 21 CFR Part 11, and Data Integrity.

• Experience with clinical development systems or Health IT.

• Robust project management experience, including PMO responsibilities.

• Ability to operate within complex, cross-functional, and matrix organizations.

• Fluent in English; English is the mandatory working language.

• Experience with R Shiny applications and frameworks is a plus.

• Familiarity with Power BI dashboards is advantageous.

• Knowledge of Agile/SCRUM methodologies is preferred.

• Proficiency in French or Dutch is a bonus but not compulsory.

🏝️ Benefits

• Flexible remote work arrangement.