100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have! #GCO
The Good Clinical Practice (GCP) Compliance Manager (Americas Hub) is accountable for the compliance oversight and control of regulated GCO activities focusing on Americas Hub & Country level delivery including country trial level conduct as per country assignment. This role contributes to all compliance activities supporting the three pillars of GCP Compliance, issue management, audits & inspections as per country assignment and GCO self-strategy delivery.
Your responsibilities include, but are not limited to:
•Single point of contact for Americas Hub & Country team members for GCP Compliance
•Management and day-to-day support provided in program/trial level quality issues, deviations and quality events management
•Coordination and support to program / trial delivery teams for audits and inspections based on trials’ selection and audit / inspection scope
•Delivery of the GCO self-assessment strategy related checks and controls
•Support cross-functions risk assessments if program/trial/country level in scope and contribute to the monitoring of relevant indicators/metrics/thresholds
•Contribute to the execution of the GCO GCP Compliance strategy under the leadership of the GCP Compliance Head (Americas hub)
•Drive the compliance oversight and control of regulated GCO activities focusing on Americas Hub & Country level delivery including country trial level conduct as per country assignment, working closely with the Hub & Country teams members, the relevant functions across GCO, involving and collaborating as required with GDD and the wider organization, such as Quality Assurance
•Be the single point of contact for Americas Hub & Country team members as per country assignment for GCP Compliance
This position is eligible to hybrid working principles.