In my current position I am managing the global Veeva Regulatory Information Management system of MSD Animal Health. In 5 years time we transformed a paper based R&D organization to a one source digital based organization with worldwide harmonized business processes from drug discovery to regulatory submission.My responsibilities focus now on:1. Master data management2. Change management to improve processes3. Governance (business and system procedures, risk and domain management)4. User and technical support (interfaces and tools)I have over 40 years IT Project Management and Business Analysis experience in healthcare ranging from clinical systems, pharmacogenetics and data privacy, clinical data warehouses and clinical trial statistical programming and clinical data/coding standards (e.g. CDISC/MedDRA).I have a passion to combine my medical knowledge and IT profession to improve healthcare processes and information delivery. My Lean Six Sigma, Business Process Management, Prince2 and QA experience helps to improve processes and define IT solutions if needed. I was involved in three strategic initiatives of Organon:1. Redesign the drug discovery process and introduce High Throughput Screening (robotics lab).2. Excellerate the world wide clinical process by introduction of global systems.3. Facilitate personalized medicine R&D by combining genetic and clinical data in a Data Warehouse.Leading multi-disciplinary teams of medical and IT professionals is still inspiring me to create the best solutions. Combining the knowledge of the 'hard' IT environment and the soft skills needed for team work is one of my assets to drive successful projects. I managed many enterprise wide projects in crucial parts from specification, design, buy/build decision, implementation and maintenance: Oracle Clinical (WHO-DRUG thesaurus, NormLab, eLoader), SAS/BI data warehouse and data migration, Cognos reporting, Electronic Data Capture systems (e.g. ClinWare, TeamWorks), Microsoft SQL server/.Net based Clinical Trial Management System and Interactive Voice Response System/patient randomization (MS SQL server). An important part of the projects was the organizational and IT change management (e.g. support business management, train end users and IT support). I am open and interested in people and value diversity. In project teams this creates an open communication climate and stimulates collaboration and fun which in my view is the best way to success for individuals and organizations.
Listed skills include Clinical Trials, Validation, Ctms, Pharmaceutical Industry, and 31 others.