Thomas Katzenberger

About Thomas Katzenberger

I enable complex global programs to operate with clarity, speed, and excellence through digital innovation, data-driven governance, and cross-functional alignment.Senior Clinical Operations & Digital Program Leader with 20+ years of global experience driving operational excellence across clinical technologies, digital trial enablement, supply chain, and large-scale program delivery. I specialize in transforming complex operating models, leading cross-functional teams, and improving global execution through AI-enabled automation, governance frameworks, and data-driven decision making.I bring deep expertise in: Clinical Operations & Digital Trial Technologies (eCOA, eConsent, DCT, hybrid models) Program & Portfolio Leadership across global studies and enterprise initiatives Operating rhythms, PMO frameworks & cross-functional alignment UAT, SDLC, validation readiness & digital deployment cycles Vendor governance, KPIs, scorecards & operational performance AI-enabled productivity, automation & workflow optimization

Experience

1. Senior Manager, Ecoa Management

   Bristol Myers Squibb

   Dec 2022 — Present · Lawrence Township, NJ, US

   Provide leadership for end-to-end eCOA operationalization, collaborating with vendors and internal cross-functional teams to ensure successful study implementation. Responsibilities encompass all eCOA operational activities, from study start-up through conduct and closure. During start-up, collect requirements for eCOA vendors, review SOWs, and initiate Change In Scope processes. Streamline processes, document templates, and interactions to facilitate effective eCOA implementation. Ensure quality oversight and management of external partners performing eCOA activities. Lead continuous improvement initiatives to create an industry-leading eCOA capability. Represent the department in Health Authority inspections and internal audits, ensuring effective preparations and follow-up actions. Maintain procedural documents to reflect industry standards and regulatory requirements. Resolve eCOA issues during study conduct in collaboration with study team members and vendors. Support the mentoring and training of newly hired team members. Oversee User Acceptance activities for eCOA, ensuring meticulous planning, execution, and documentation. Extensive experience in the therapeutic areas of Immunology, Cardiovascular, Neuroscience, Hematology, Oncology, and Cellular Therapy.

Education

• Euro-FH Europäische Fernhochschule Hamburg

  Diplom-Kaufmann (FH), Business Administration

• Euro-FH Europäische Fernhochschule Hamburg

  Bachelor of Arts - BA, Business Administration