GCP Compliance Specialist / Manager (Technology)

Summary

The GCP Compliance Specialist (Technology) is accountable to manage delegated activities supporting GCO projects and teams in ensuring compliance against GCP for emerging technology and change of strategy in current GCO managed technology, including awareness of the use of artificial intelligence (AI) and machine learning in GCO operated clinical trials, with the aim to guarantee regulatory adherence in the use of computerized systems and in the collection of electronic data.

The GCP Compliance Specialist (Technology) provides data analytics and reporting support, knowledge in GxP relevant Enterprise IT systems in the frame of GCP Compliance activities and supports the delivery of the GCP Compliance Technology roadmap. This role promotes a product quality culture within GCO supporting the GCP Compliance Head (Technology), focusing on quality and compliance being increased and sustained.

About The Role

Major accountabilities :

• Contribute to the compliance against GCP for emerging technology and change of strategy in current GCO managed technology via assigned activities.
• Support the delivery of the GCP Compliance Technology roadmap via assigned activities.
• Provide data analytics and reporting support in the frame of GCP Compliance activities.
• Provide day-to-day technical support with knowledge in GxP relevant Enterprise IT systems to GCP Compliance teams and GCO teams.
• Support the monitoring of relevant indicators / metrics / thresholds if relevant per scope.

Key Performance Indicators

Minimum Requirements

Education : Minimum : Bachelor's degree in science, B.Pharma, M.Pharma, Computer Science engineering or relevant discipline.

Language : Proficiency in English.

Experience / Professional Requirement

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Skills Required

Data Analytics, clinical operations , Machine Learning, Artificial Intelligence, Regulatory Requirements