Ben Fancke

Director of Project Delivery | Healthcare & Clinical Trials Operations | PMP & Lean Six Sigma | GxP/ICH-GCP Compliance | PhD Scientist

Mont-sur-Rolle, Vaud, Switzerland

About

I am a clinical operations leader and PhD-trained immunologist with over 15 years of experience managing complex, data-driven clinical technologies across global CRO, biotech, and pharmaceutical environments. I bring a practical approach to project delivery, combining my scientific background with PMP and Lean Six Sigma methodologies to translate advanced scientific requirements into repeatable, compliant services. In recent roles, I built high-performing teams across Switzerland and Singapore and managed the deployment of regulated laboratory workflows for over 40 oncology-based clinical trials. My focus is on operational governance, financial discipline, and ensuring clinical trials are delivered on time and within budget. To drive this, I developed digital dashboards to improve financial forecasting and resource allocation, and I led Lean operational excellence programs that increased sample processing capacity by 68% while maintaining a 99.6% on-time turnaround. I partner effectively across clinical, data, and commercial teams to ensure that innovation is executable, scalable, and compliant with ICH-GCP, ISO, and CAP regulations.

Experience

  • Project Manager - Digital Integration at Merck Group
    Oct 2024 - Mar 2025 · 6 mos

    I acted as a project manager and supported the digital integration project for the Merck Biotech Development Centre (BDC), advancing the implementation of their digital ONE Lab solutions. In this role, I coordinated multidisciplinary and cross-functional teams to enhance laboratory informatics, workflow automation, data management, and collaboration capacity for the Drug Product Development team. > Digital Ecosystem Architecture: Managed the integration of next-generation laboratory informatics solutions (LIMS/ELN), breaking down data silos between wet-lab operations and data science teams. > Supported the implementation of digital-first workflows that reduce manual data entry friction, accelerating the "Design-Make-Test-Analyse" cycle for drug product development.

  • NeoGenomics Laboratories (3 yrs 10 mos)
    • Associate Director of Operations, Pharma Services
      Jun 2022 - Jul 2023 · 1 yr 2 mos

      Directed the operational strategy and clinical service delivery for the European Pharma Services division, with full accountability for quality systems, financial performance, and people leadership. I focused on building an inspection-ready organization and driving measurable gains in clinical consistency to support global oncology programs. > Managed end-to-end project support and study startup activities for over 40 oncology-based clinical trials, ensuring seamless integration of laboratory services. > Led a structured Lean operational excellence program that simplified laboratory workflows, delivering a 68% increase in sample processing capacity and maintaining a 99.6% on-time turnaround performance. > Developed a robust clinical quality management framework that reduced quality incidents, achieving zero deficiencies or non-conformities across all ISO and CAP regulatory audits in 2021 and 2022. > Managed the end-to-end closure and validated tech transfer of the Swiss central laboratory to the UK, maintaining zero service disruption while overseeing timeline and budget adherence. > Built a culture of continuous improvement and leadership engagement, which reduced staff turnover and positioned the EU site as the top-rated location internally for work environment and communication.

    • Senior Scientist, Europe & Asia Pacific
      Oct 2019 - Jun 2022 · 2 yrs 9 mos

      Established and lead multinational scientific and operational teams (Switzerland and Singapore) responsible for the delivery of complex clinical laboratory services. Partnered closely with pharma/biotech sponsors to translate trial protocols into standardized, compliant testing services offered through Europe and the Asia Pacific. > Managed the cross-regional investigation of laboratory workflows between Switzerland and Singapore, leading the project management and subsequent harmonization of analytical platforms. This standardization ensured strict data uniformity, consistent turnaround performance, and regulatory compliance across global EU and APAC sponsor studies. > Managed the implementation and ongoing governance of 8 laboratory-developed diagnostic assays (LDTs), over 30 exploratory protocols, and 4 novel diagnostic platforms. > Engineered digital productivity dashboards to establish real-time leading indicators, forecasting clinical capacity and systematically eliminating operational bottlenecks to optimize resource utilization. > Managed the RFP process and pricing for new clinical trial projects and test offerings, driving financial discipline across the portfolio through rigorous SOW review and change order management. Oversaw study setup, supplier selection, and resource planning, ensuring accurate financial forecasting and strict scope control to support seamless clinical trial integration.

  • Lead Scientist: Immunology Clinical Trials at Peter MacCallum Cancer Centre
    Aug 2017 - Sep 2019 · 2 yrs 2 mos

    I acted as the primary operational and scientific lead for immunology clinical research projects, supporting early- to late-phase (Phase I–III) clinical programs. I focused on translating sponsor requirements into scalable, reproducible testing services while balancing timelines, budgets, and scientific integrity. > Built a scientific testing team from conception to six staff within two years, directly contributing to the award of new contracts including three international Phase III trials covering Flow Cytometry, Cell Culture, Cytogenetics, FISH, and Immunoassay disciplines. > Managed a major Phase III program to completion on time and within budget, with end-to-end responsibility for resourcing, procurement coordination, and quality oversight. > Conceptualized and implemented standardized workflows between central pathology laboratories and clinical trial units, reducing testing turnaround times and optimizing resource allocation to accelerate overall study outcomes. > Supported sponsors directly by handling SOW reviews, identifying risks, resolving issues, and maintaining strong client relationships.

  • Senior Scientist at 360biolabs Pty Ltd
    Aug 2015 - Aug 2017 · 2 yrs 1 mo

    Managed the technical execution and quality compliance of regulated laboratory testing for multi-center national and international early-phase clinical trials. My focus was on ensuring that all assay design, test implementation, and rigorous clinical data generation. To achieve this, I led the design and validation of clinical assays with a strict emphasis on operational implementation, analytical robustness, and longitudinal repeatability, ensuring consistent data quality and reliable delivery to sponsors. > Provided specialized technical expertise to enhance laboratory capabilities, driving successful alignment and execution of complex clinical trial projects. Regularly hosted internal and external audits, ensuring readiness and adherence to OECD Principles of Good Clinical Practice (GCP). > Fostered strong collaborative relationships with stakeholders and clients, supporting regulatory inspection preparedness and maintaining compliance with all relevant procedures and regulations. Spearheaded initiatives for Regulatory Authority inspections, ensuring continuous improvement and regulatory adherence.

  • Macfarlane Burnet Institute for Medical Research and Public Health (Burnet Institute) ()
    • Senior Research Associate
      Jul 2010 - Aug 2015 · 5 yrs 2 mos

      Conducting immunological research into the foundations of innate and adaptive immune responses. Laboratory management, immunology research and the training and supervision of staff and students.

    • PhD Candidate
      Apr 2011 - Apr 2015 · 4 yrs 1 mo

      Monash University PhD investigating the initiation of immune responses during infection by novel immune cell types identified in the bone marrow. The design and implementation of research objectives, novel laboratory assay development and optimization, training and supervision of fellow staff and students, the development and approval of ethics protocols for the collection of human samples for research, the recruitment and coordination of hospital staff for the collection of experimental samples from the Alfred Hospital, proficient laboratory based cell biology techniques.