Operational Excellence Manager - Biometrics & Data Sciences

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