Christopher Higgins Email & Phone Number

Carlsbad, Ca

• Manage Drug Development Information Systems department, including Data Management and Systems personnel.• Work with Data Management to plan and allocate internal and vendor resources for over two dozen clinical studies.• Responsible for integration of Clinical Trial Management system, including acquisition of data from multiple CRO, IVRS and SAE vendors.• Responsible for design of CTMS SharePoint portal, including portfolio, program and study home pages, as well as data lists, graphs and integrated reports for consumption by Drug Development department.• Facilitate review and revision of document management process pertaining to the Trial Master File with Clinical Operations group.• Participate in development of predictive analytics engine in conjunction with SAS in order to improve clinical study decision-making process.• Work with various other Clinical Development groups (Regulatory, Quality, Data Management) to review current processes and propose alternative technical solutions to increase efficiency.

Greater San Diego Area

• Manage and support mission-critical Electronic Data Capture and Clinical Trial Management Systems for Clinical Affairs.• Develop programs used to collect and monitor data across critical clinical studies.• Develop data-driven reports integrating SQL Server and Oracle clinical study and study management data.• Develop database solutions (tables, triggers, functions, procedures, views) in both SQL Server and Oracle DBMS in support of clinical data initiatives.• Support Oracle DBMS, including job monitoring, resource utilization, system health and application installation and upgrades.• Create and manage Clinical Affairs SharePoint servers, including site development, maintenance and security.• Maintain and enhance CTMS SharePoint portal through list and library development, workflow enhancement and report development.• Design and develop reporting, system security and technology strategies for department.• Lead Clinical Affairs in new system acquisition and upgrades, including vendor analysis and evaluation, budgeting, system implementation and system validation (IQ/OQ/PQ).• Lead database development standardization team tasked with creating Clinical Affairs department study CRF standards.• Lead process development within CDM group including work instruction development and periodic review of over 40 CDM-specific process documents.• Advise Clinical Science, Medical Writing and Clinical Operations with regards to data acquisition issues and propose solutions to clinical data needs.• Responsible for oversight and annual review of Clinical Data Management staff of database developers and data analysts.• Plan resources for database development activities and develop budgets and project plans for CDM group.• Monitor the development and implementation of clinical study databases, including review and approval of deliverables and on-time delivery of studies.• Advise management of resource issues and lead CDM team in hiring process for additional headcount.

Greater San Diego Area

• Responsible for the design and implementation of company-wide, data warehouse reporting solution.• Conducted project meetings with executive-level staff, data warehouse vendor and internal project resources to coordinate testing, design changes, warehouse configuration and project scope.• Provided high-level design specifications and data warehouse best practices to vendor in charge of implementation.• Reported project status, negotiated resource availability, provided project timelines and defined acceptance criteria for overall project.• Verified SQL Server database setup and access needs as well as BusinessObjects reporting environment.• Assisted in testing and data validation through creation of complex SQL queries and stored procedures.• Assisted in construction of BusinessObjects Webi and Deski reports to replicate current in-production reports.

Greater San Diego Area

• Led company-wide data warehouse initiative, including management of project resources consisting of internal personnel, consultants and executive management.• Assessed data needs of user community and architected dimensional and fact-based data model based on executive management and commercial operations requirements.• Worked with developers to create and maintain DTS packages to assimilate warehouse data from multiple database systems and mediums (Oracle, Essbase, SQL Server, Excel) into staging, repository and mart databases.• Provided support for report designer in the creation of Business Objects universe and reports for data warehouse.• Served as SQL Server database administrator responsible for daily database maintenance, DTS package creation and job processing.• Supported and developed Visual Basic applications for research community to collect and store clinical research and drug supply data.• Coordinated and implemented company intranet via content updates and programming using content management system.• Versed and proficient in other development tools, including multiple scripting languages, source code control management systems and installation development tools.

Carlsbad, Ca

Syracuse, New York Area

Syracuse, New York Area