Michael Inkmann

Background

About Michael Inkmann

Senior thought leader with 20+ years of experience (including more than 40 clinical studies) in clinical data strategy and excellence in operational management. Demonstrated elite end-to-end data process management across complex Phase I to Phase IV clinical trials. Known for continuous improvement, forward-looking innovation, and efficiency that delivers data quality, integrity, and timeliness. A leader who builds and mentors high-performing teams. Comfortable in fast-paced matrixed team environments. Relentless curiosity—always learning. Core competencies: · Clinical data strategy and management · Data integrity and compliance/best practices · Data cleaning, reporting, analytics, and visualization · Regulatory subject matter expert: FDA, EMA, CDISC, CDASH, ICH GCP, GCDMP · Data collection, cleaning, tabulation, analysis, reporting/electronic data capture (EDC) · Data review rules, study-level tables, listings, figures · SDTM mapping, ADaM mapping and derivation, TLF, Analysis Results · Exploratory data analysis · Complex simultaneous global clinical trial management · Budgets, forecasts, timelines, resource planning · Creation SOPs and Work Instructions, CDM TMF, user acceptance testing (UAT), eCRF design, database design and implementation, · CRO, FSP, vendor negotiation, and management · Vendor qualification and oversight audits · Technology evaluation, qualification, and selection · Interactive Response Technology (IRT), IWRS and IVRS · Standardization, automation, technical enhancements, and process improvement · Cross-functional collaboration/consensus building · Data Science – Supervised and unsupervised learning