Ricerca aperta dal 11/05/2026 al 20/07/2026
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
Develop Capabilities & Culture
- Identify training needs and coordinate development programs
- Support onboarding and continuous learning initiatives
- Promote a culture of accountability, collaboration, and excellence
Support Strategy & Governance
- Partner with the BDS Director on operational governance and portfolio prioritization
- Contribute to dashboards, KPIs, and executive-level reporting
- Support the execution of departmental strategy
Education
- Degree in a scientific or quantitative discipline
(e.g., Statistics, Data Science, Computer Science, Mathematics or related field)
Experience
- 5–8 years of experience in biometrics, clinical research, or related R&D roles
- Solid understanding of clinical development (Phase I–IV) and Medical Affairs evidence generation
- Proven experience in:
- Operational planning and delivery of biometrics activities
- CRO/vendor oversight
- Budget and financial management
Skills
- Strong knowledge of clinical trial processes, GCP, and regulatory requirements
- Good understanding of biometrics disciplines (statistics, programming, data management, data science)
- Excellent organizational, analytical, and problem-solving skills
- Strong communication and stakeholder management capabilities
- Proactive mindset with a continuous improvement focus
