Stratmann-sebastian
Manager
Pharmaceutical Sciences
Merck Group
Germany
Biography
Experienced expert in scope of Clinical IT systems, Clinical Research, Drug Safety, Regulatory Affairs, eClinical, International Project Management, In-depth understanding of R&D Process, R&D IT Business Partner, R&D Process development, R&D Process improvement, Lean six sigma, System analysis, System implementation, Strategic Partnership, New R&D business model, Change Management, Clinical Trial Management System, Business Objects XI, IBM Cognos, Q-Infosario, 21 CFR Part 11, GxP, eCRF, EDC, ePRO, RDC, IVRS, ClinPhone, Monitoring of clinical Trials, Phase II-IV, Invesitgator sponsored trials, Feasibility, non-interventional studies, ICH-GCP, Pharmacovigilance, SAE Reporting, SUSAR distribution management, Clinical Quality Assurance, Quality and Compliance, R&D Applications, Planisware, Regulatory Affairs Information Management System, Electronic Document Management System, Real World Data, Real World Evidence, Clinical Data Analytics, Health Outcome, Data Lake, Clinical Reporting
Research Interest
Clinical IT systems
