Job Details
Operational Excellence Manager – Biometrics & Data Sciences
6120
Posted: 18/02/2026
- €70000
- BW, Belgium
- Permanent
Operational Excellence Manager – Biometrics & Data Sciences
Reporting to: Biometrics & Data Sciences Director
Job Type: Full-time
Position Overview
The Operational Excellence Manager will lead and continuously improve the operational framework of the Biometrics & Data Sciences (BDS) department, covering the drug development needs, in particular the biometrics activities from Phase I to Phase IV as well as Medical Affairs evidence‑generation programs. The role ensures the efficient planning, execution and oversight of biometrics activities—including statistics, statistical programming, data management, and data sciences—across multiple clinical studies and key departmental initiatives.
This position is central to ensuring operational discipline, budgetary accuracy, high‑quality deliverables, and compliance with internal SOPs, external regulations, and corporate governance. The role partners closely with the Biometrics & Data Sciences Director to drive performance excellence, standardization, training, and continuous improvement across the function.
Key Responsibilities
Operational Planning & Oversight
Qualifications & Experience
Education
What We Offer
If you’re ready to drive operational excellence in biometrics and make a tangible impact across the development lifecycle, please get in touch: aimee@warmanobrien.com
Reporting to: Biometrics & Data Sciences Director
Job Type: Full-time
The Operational Excellence Manager will lead and continuously improve the operational framework of the Biometrics & Data Sciences (BDS) department, covering the drug development needs, in particular the biometrics activities from Phase I to Phase IV as well as Medical Affairs evidence‑generation programs. The role ensures the efficient planning, execution and oversight of biometrics activities—including statistics, statistical programming, data management, and data sciences—across multiple clinical studies and key departmental initiatives.
This position is central to ensuring operational discipline, budgetary accuracy, high‑quality deliverables, and compliance with internal SOPs, external regulations, and corporate governance. The role partners closely with the Biometrics & Data Sciences Director to drive performance excellence, standardization, training, and continuous improvement across the function.
Operational Planning & Oversight
- Coordinate and oversee operational planning of biometrics activities for clinical trials (Phase I–IV) and Medical Affairs studies.
- Ensure realistic timelines, workload projections, and resource planning in collaboration with functional leads.
- Monitor operational progress, identify risks, drive mitigation strategies, and ensure timely, compliant deliverables.
- Serve as the operational interface with external CROs providing biometrics services.
- Review biometrics scopes, deliverables, timelines, and performance metrics.
- Ensure alignment with internal quality standards, study requirements, and corporate policies.
- Lead budgeting activities for biometrics deliverables across the portfolio (study- and program-level).
- Review and negotiate CRO cost proposals, budgets, and work orders in collaboration with Procurement and Finance.
- Monitor expenditure, manage accruals, and support long-range financial planning.
- Drive continuous improvement initiatives and operational excellence across all biometrics functions.
- Maintain and enhance departmental processes, workflows, and SOPs in alignment with GCP, regulatory expectations, and best practices.
- Facilitate process harmonization with cross-functional stakeholders (Clinical Operations, Regulatory, QA, IT, Medical Affairs).
- Support audit/inspection readiness for biometrics-related activities.
- Ensure processes and deliverables adhere to ICH-GCP, regulatory guidance, and internal QMS.
- Embed quality-by-design principles into everyday biometrics operations.
- Identify training needs across the BDS department and coordinate targeted training programs.
- Implement onboarding and continuous education frameworks for internal staff and external partners.
- Promote a culture of operational excellence, accountability, and high scientific standards.
- Act as a strategic partner to the Biometrics & Data Sciences Director in operational governance, portfolio prioritization, and departmental strategy execution.
- Support departmental reporting, KPIs, dashboards, and governance presentations.
Education
- University degree in a scientific/ project management field is required.
- Preferred degrees: Statistics, Statistical Programming, Computer Science, Data Science, Mathematics, or related quantitative discipline.
- Minimum 5–8 years in biometrics, clinical research, or related R&D roles within the pharmaceutical or biotechnology industry.
- Solid understanding of clinical development across Phase I–IV and Medical Affairs evidence‑generation models.
- Demonstrated experience planning biometrics activities and managing cross-functional timelines.
- Strong track record in CRO oversight, including operational and financial aspects.
- Proven experience managing budgets, cost evaluations, proposals, contracts, and work orders.
- Strong knowledge of clinical trial processes, GCP, and regulatory requirements.
- Familiarity with biometrics disciplines (statistics, programming, data management, data science).
- Excellent organizational, prioritization, and analytical thinking skills.
- Excellent communication skills and ability to influence both internal stakeholders and vendors.
- Proactive mindset, continuous improvement orientation, and problem-solving attitude.
- A strategic role at the heart of R&D biometrics operations.
- Opportunity to shape operational excellence, processes, and culture within a growing department.
- Collaboration with cross-functional teams, innovation‑focused environment, and exposure to global drug development.
If you’re ready to drive operational excellence in biometrics and make a tangible impact across the development lifecycle, please get in touch: aimee@warmanobrien.com
Aimee Weston
Principal Consultant in Biostatistics
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