Heike Kenner

🧬 Clinical Operations & Vendor Management Professional | Neurology, Gene Therapy & Oncology | Global Trial Execution 🧬

Switzerland

About

🎯 Experienced & Purpose-Driven Clinical Operations Professional with 14+ years of delivering complex, global clinical trials across neuroscience, gene therapy, and oncology — including pivotal Phase III studies. I have contributed to the marketing authorization of a treatment for multiple sclerosis, and supported the delivery of important safety and efficacy data for pediatric patients with spinal muscular atrophy. Recognized for operational excellence, cross-functional leadership, and a steadfast commitment to quality, compliance, and patient-centric outcomes. 🔬 I have led and owned key operational activities across Phase II–IIIb trials in both pharmaceutical and non-profit cooperative group settings. My expertise spans trial execution, vendor management and oversight, risk mitigation, and coordination across complex stakeholder landscapes. I bring deep experience overseeing critical vendors — including central labs, eCOA/PRO, IRT, and clinical supplies — ensuring inspection readiness, timely issue resolution, and smooth integration into trial workflows. 🤝 I’m a structured, solutions-oriented team player who values clear, proactive communication as the foundation for trust, alignment, and effective collaboration. I thrive in complex environments, where I bring clarity, consistency, and coordination across stakeholders to drive timely, high-quality trial execution — always with the patient in focus. 🛡️ I bring a proactive, detail-focused approach to trial execution and vendor oversight, with quality and compliance at the center of every decision. I ensure alignment with GCP, internal standards, and regulatory expectations — from inspection readiness and data integrity to issue resolution. I take full ownership of my work and strive for operational excellence that is reflected in high-quality outcomes and a strong commitment to the patient. _________________________________________ 🔑 Core Competencies & Keywords Clinical Operations | Phase II–IIIb Trials | Neuroscience | Gene Therapy | Oncology | Regulatory Compliance | GCP | Trial Start-Up to Database Lock | Vendor Management & Oversight | CRO Collaboration | Risk Mitigation | Inspection Readiness | Quality Assurance | IRT | eCOA/PRO | Central Labs | EDC | Clinical Supplies | Data Integrity | TMF Management | Operational Strategy | Trial Tools & Documentation | Cross-Functional Collaboration | Stakeholder Coordination | Patient-Centric Approach | Clinical Development Excellence

Experience

  • Professional Sabbatical | Learning, Growing & Shaping the Next Chapter in Healthcare at Self-directed
    Feb 2025 - Present · 1 yr 5 mos

    After more than 14 years in clinical research, operations, and vendor management, I made a conscious decision to step back from full-time work to take a professional sabbatical. During this period, I have: • Strengthened project management expertise through targeted self-learning • Explored digital/AI trends to build broader digital fluency • Reaffirmed my commitment to contributing to meaningful, patient-focused healthcare innovation This time has provided valuable space for reflection, growth, and renewal — preparing me for the next chapter of my career journey. I am ready to embrace new challenges, continue learning and growing, and make a positive impact on patients and the people I work with.

  • Novartis (Basel, Switzerland)
    • Vendor Trial Senior Manager
      Aug 2023 - Jan 2025 · 1 yr 6 mos

    • Expert Global Trial Manager
      Apr 2016 - Jul 2023 · 7 yrs 4 mos

  • Clinical Project Manager at Swiss Cancer Institute
    Mar 2011 - Mar 2016 · 5 yrs 1 mo

  • Trainee at University Hospital Zürich, Clinical Trials Center
    Dec 2010 - Feb 2011 · 3 mos