Full time managing and supporting global clinical and enterprise systems projects and/or regulated data management...Working in Clinical * R&D * IT * Regulatory/CMC * Quality * Compliance * Validation * Supply Chain * Manufacturing * eDiscovery * Governance * Analytics Project Management, Business Systems Architecture/Analysis, Quality Analysis, Regulatory Submissions & Tracking, Pharmacovigilance (PV), Process Improvement, UAT, Verification & Validation, and more...===============================================================Successful at leading/mentoring teams in the concept, design, development, and deployment of quality cost-effective data collection and reporting solutions. Design and deployment of risk-based validated solutions that emphasize innovative use of information technologies and tools to support enterprise & clinical global business objectives. Clients include Johnson & Johnson (Centocor/Janssen), Merck, Pfizer, AstraZeneca, ICON, Boehringer Ingelheim, Cenveo, Merck-Serono, Medtronic, CSL Behring, Allergen, etc.Expertise: Content-Records Management, Workflow Management, Master & Integrated Data Management, Database Management, Business Intelligence, Quality Systems Management, Applications Management, Business Process Management, Workforce Management (Onsite/Remote Teams), Change Management, Risk Management, Business Development, Equipment and Software Validation/Testing...Migration Strategy and Planning (Migration Center)... includes CTMS, CTMF, CDMS, and EDC development, reporting and analysis, training, custom applications, team building, technology consulting and business process reviews.
Listed skills include Business Intelligence, Sharepoint, Business Analysis, Integration, and 46 others.