Tim Cooley Email & Phone Number

California, United States

Consulting services on integrating IT into operations for the Diagnostics and Life Science Industries while maximizing ROI and improving compliance and security. Providing interim IT and Operations leadership upon request. Specialties:P&L, Scientific Computing, Collaboration Management, Laboratory Operations, NGS, Genomics, Precision Medicine, Healthcare Software Solutions, Software Development, FDA, 21 CFR Part 11, GxP, GCP, GLP, CMS Regulations, HIPAA, CLIA, CAPA, ISO14385, ISO15189, LIMS, Contract Negotiations, Outsourced Solutions, Oncology, Bioinformatics, Informatics, Product Management, Cloud Product Offerings, Client Experience, Clinical Decision Support Software, Customer Segmentation, Process and Capability Assessment, Lean Six Sigma, Infrastructure Management, PaaS, SaaS, PMO, Budgeting, Business Relationship Management, Laboratory, Agile Software Development, Virtualization, VMware, Policy and Procedure Compliance, Budget Control, Clinical Information Management, Turnaround Management, CRM, ERP, SAP, Helpdesk, ITIL, International Teams, Portfolio Management, Software Validation, Performance Management, Career Development Frameworks.

Los Angeles, Ca, Us

San Jose, California, Us

Heidelberg, De

P&L accountability in the Americas for comprehensive software, molecular diagnostics and lab services offering supporting precision medicine in oncology. Scope of responsibilities includes IT, Customer Service, Medical Services, Laboratory Operations, Product Management and Professional Services.• Developed and executed strategies for the delivery of lab, medical and IT products and services in the in the Americas including obtaining CLIA and ISO certifications for the integrated software and laboratory service offering.• Established a global operations oversight team and drove harmonization of processes and metrics across customer service, the laboratory medical and IT.• Implemented multiple HIPAA compliant systems including a LIMS, customer portal, informatics and results reporting tools.Specialties: Site Leadership, P&L, Scientific Computing, Collaboration Management, Laboratory Operations, NGS, Genomics, Precision Medicine, Healthcare Software Solutions, Agile Software Development, Distributed Teams, CMS Regulations, HIPAA, CLIA, CAPA, ISO14385, ISO15189, LIMS, Contract Negotiations, Outsourced Solutions, Oncology, Bioinformatics, Informatics, Product Management, Client Experience, Clinical Decision Support Software, Customer Segmentation, PMO, Process and Capability Assessment, Lean Six Sigma, Infrastructure Management, Cloud Product Offerings, PaaS, SaaS, Budgeting, Agile Software Development, Virtualization, VMware, Policy and Procedure Compliance, Budget Control, Healthcare Management, Clinical Information Management, Turnaround Management, CRM, ERP, SAP, Helpdesk, ITIL, International Teams, Portfolio Management, Software Validation, Customer On-boarding, Performance Management, Career Development Frameworks.

Toledo, Oh, Us

Responsible for all aspects of IT for NAMSA including strategy, and the development and operation of a streamlined global IT organization driving value and innovation.• Worked with Business Unit Leaders across the organization to integrate local IT teams, infrastructure and systems from multiple acquisitions into a multi-site global IT organization, supporting corporate functions (ERP, finance, CRM), global laboratory operations and clinical/regulatory consulting business units (GxPs), and a distributed sales team while managing double digit growth in revenue.• Implemented a company wide portfolio management process to value and prioritize key IT investments across the company. Resulted in the launch of several key projects including customer portals, CRM, integration of multiple financial systems, and redesign of the Laboratory Information System (LIMS).Specialties:Scientific Computing, IT Governance, Infrastructure Management, Infrastructure Design, M&A Integrations, Software Development, Distributed Teams, FDA, 21 CFR Part 11, GxP, GCP, GLP, LIMS, Software Validation, Cloud Computing, SaaS, PMO, Project Management, Budgeting, Business Relationship Management, Toxicology, Medical Device, Agile Software Development, Scrum, Clinical Trial Software, CTMS, Virtualization, VMware, Policy and Procedure Compliance, Budget Control, Clinical Information Management, Turnaround Management, CRM, ERP, Accounting Software, Helpdesk, ITIL, International Teams, Portfolio Management, analytical chemistry systems, veterinary sciences, Regulatory Affairs, CAPA, Performance Management, Career Development Frameworks.

Indianapolis, Indiana, Us

Responsible for $15M strategic IT investment for Global Health Outcomes, US Medical and Global Product Teams for Lilly Products (>1500 Global Users). Delivered multiple externally facing products including redesign of sites supporting physicians in the US and tools supporting evaluation of Outcomes data for providers. Aligned IT, information systems and informatics capabilities with business requirements in a complex regulatory environment to deliver against business objectives.Specialties:Scientific Computing, Informatics, Agile Software Development, Scrum, Distributed Teams, PMO, Project Management, Budgeting, Business Relationship Management, Statistics, FDA, 21 CFR Part 11, GxP, GCP, GLP, Health Economics Tools, Real World Data, REMS, Content Delivery, Digital Strategies, Market Segmentation, Persona Development, Organization Change Management, Policy and Procedure Compliance, Budget Control, HIPAA, Clinical Trial Software, CTMS, Medical Content Fulfillment, Turnaround Management, Lean Six Sigma, International Teams, Portfolio Management, Regulatory Affairs, CAPA, Performance Management.

Indianapolis, Indiana, Us

Provided IT and site leadership for a dynamic technology oriented research startup wholly owned by Eli Lilly. Accountable to Singapore Economic Development Board and Lilly for >$100M in research and technology grants. Drove bioinformatics portfolio delivering enterprise level systems and research tools. Accountable for all aspects of IT including solution delivery, data centers and identifying and managing vendor collaborations within Asia.• Delivery of a variety of systems ranging from tools to manage gene expression data and experiments to tools to explore pathway, genetic and histology in highly integrated datasets recognized globally within Lilly and by the company’s scientific advisory board for impact and innovation.• Built a distributed scientific software development organization which exceeded all delivery and operational metrics.• Sponsored and lead a diverse range of global and regional initiatives in portfolio management, IT architecture and talent development.Specialties: Genomics, Startup Management, Site Leadership, Scientific Computing, Agile Software Development, Scrum, LIMS, FDA, 21 CFR Part 11, GxP, Contract Negotiations, Outsourced Solutions, Collaboration Management, Oncology, Bioinformatics, Informatics, HPC, Infrastructure Management, PMO, Budgeting, Business Relationship Management, IT Governance, Laboratory, Policy and Procedure Compliance, Budget Control, Helpdesk, Distributed Teams, International Teams, Portfolio Management, Performance Management, Career Development Frameworks, International Compensation Analysis.

Indianapolis, Indiana, Us

Provided leadership to IT teams supporting business and scientific operations for Toxicology. Envisioned and drove re-engineering of key systems and business processes as a part of retirement of legacy systems. Accountable for ensuring systems supporting environmental controls, laboratory automation, site project management, data collection and pathology were maintained and operational 24/7,.Specialties:Infrastructure Management, Software Development, LIMS, PMO, Project Management, Distributed Teams, Budgeting, Business Relationship Management, Toxicology, FDA, GLP, GMP, Pre-clinical Systems, Laboratory, Software Validation, Policy and Procedure Compliance, Budget Control, Helpdesk, International Teams, Portfolio Management, analytical chemistry systems, veterinary sciences, Regulatory Affairs, CAPA, Scientific Computing, Collaboration Management, IT Governance, Performance Management.

Indianapolis, Indiana, Us

Us

Bs, Microbiology

Human Genetics