Skills:
Project Management Expertise Management of multiple globally distributed projects concurrently spanning all phases of research, development, clinical trials in the fields of biotechnology, diagnostics and medical devices. Developing and maintaining detailed cross-functional timelines with complex inter-dependencies Identification, communication and monitoring critical path activities and deliverables Estimation and forecast of project resource requirements Preparing and updating budgets (FTE and $ Spends) Tracking project progress and expenditure against baseline and budget Communicating project progress, metrics and issues to team, senior management and partners Publishing data to dashboards / scorecards Chairing cross functional meetings recording and publishing meeting minutes, decisions and tracking action items to closure Maintaining project risk register, driving development of risk-mitigation plans and flag impending risks Developing and implementing recovery plans Presenting to senior management during periodic and design reviews Conducting project close-out and lessons learned exercise Oversight and management of Clinical Trial systems used by Independent Clinical Research organization Program and Project Management for Clinical Systems projects including new system implementation PMP certified and well-versed with advanced Project Management tools and methodologies CMC, cGxP, Clinical Operation Systems Development, Device Design Control, Software Expertise Microsoft Office suite (Word, Excel, PowerPoint, Project, Publisher, SharePoint, Visio), LIMS, Clinical Information Management System (CIM), Livelink, Google Apps, Seapine Software TTP, SCM