01 ago - Italia
Altro
We are looking for an Operational Excellence Manager to join our Biometrics & Data Sciences (BDS) team within R&D.;
In this strategic role, you will drive the operational performance, efficiency, and quality of biometrics activities across the full drug development lifecycle—from early clinical phases to post-marketing and Real-World Evidence programs.
You will work closely with the Biometrics & Data Sciences Director and cross-functional stakeholders to ensure that all activities are delivered on time, on budget, and in full compliance with regulatory standards , while continuously improving processes and ways of working.
What You Will Do Lead Operational Planning & Oversight Coordinate biometrics activities across clinical trials (Phase I–IV) and Medical Affairs programs
Ensure realistic timelines, resource planning, and workload allocation
Monitor delivery progress, identify risks, and implement mitigation strategies
Drive Vendor & CRO Management Act as the primary operational interface with external CRO partners
Review scopes of work, deliverables, timelines,
and performance metrics
Ensure alignment with internal standards, study requirements, and corporate policies
Oversee Budget & Financial Planning Lead budgeting processes for biometrics activities across studies and programs
Review and negotiate proposals, budgets, and contracts in collaboration with Procurement and Finance
Monitor spend, manage accruals, and support financial forecasting
Champion Process Excellence Drive continuous improvement initiatives across biometrics functions
Maintain and optimize SOPs, workflows, and operational processes
Foster cross-functional alignment with Clinical Operations, QA, Regulatory, IT, and Medical Affairs
Ensure Quality & Inspection Readiness Support audit and inspection readiness for biometrics activities
Ensure compliance with ICH-GCP, regulatory guidance, and internal Quality Management Systems
Promote a culture of quality-by-design and operational rigor
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