Statistical Data Analyst for University-Based Research Program (May 2001 to May 2002)
Managed various databases used by a Canadian university-based Osteoporosis research and treatment program. Linked program databases to other hospital, provincial, and national databases. Analyzed data using SPSS and SAS. Served as computer and statistical consultant for the program. Improved processes for data capture and analysis.
Provided CDM Expertise to Orthopedic Device Company (August 2012 to Present)
Provided CDM services (data review, eCRF design updates, and CDM advice) for an orthopedic device clinical trial.
Director of Data Management for Small CRO/Research Clinic (February 2013 to Present)
Served as Director of Data Management for small combination CRO/research clinic. Recommended changes to CDM activities and procedures. Created full set of CDM and EDC Standard Operating Procedures. Led EDC system evaluation and selection process. Led implementation process for selected EDC system (Merge eClinical OS).Programmed CRF pages and edit checks for Merge eClinical OS.
Provided CDM Expertise for Small Biometrics CRO (February 2012 to Present)
Provided Clinical Data Management (CDM) activities for CRO clients. Provided data review and database lock assistance for two large phase III studies. Served as project manager for a SAS edit check programming project. Served as project manager for EDC builds using OpenClinica.
Performed Competitor and Technology Assessment for CRO
Performed competitor assessment and technology assessment for a small Canadian Clinical Research Organization that planned to add CDM to their existing services.
Provided CDM Support During Company Relocation (December 1998 to May 1999)
Provided CDM consulting and support services during cross-country relocation of Diagnostics division of a major international pharmaceutical company. Provided training and monitoring for laboratory sites participating in device (laboratory testing equipment) studies.
Statistical Data Analyst for University-Based Research Program (January 2003 to September 2003)
Managed various databases used by a Canadian university-based Osteoporosis research and treatment program. Linked program databases to other hospital, provincial, and national databases. Analyzed data using SPSS and SAS. Served as computer and statistical consultant for the program. Improved processes for data capture and analysis.
Provided CDM Expertise to a Small Medical Device Company (July 2012 to December 2012)
Assumed responsibility for CDM activities from previous manager who left the company. Worked with clinical team and EDC vendor to make necessary eCRF updates. Trained sites in implementing EDC changes and entering required data. Served as help desk for site EDC issues. Planned and programmed external SAS edit checks for data review that client had planned to perform manually.
Provided CDM Expertise to a Small Medical Device Company (October 2012 to Present)
Provided Clinical Data Management expertise to a small medical device company. Made recommendations on changes to CDM activities to optimize use of their EDC system. Programmed SAS edit checks for data review that could not be performed within their EDC system and for lab normal comparisons.
Provided CDM Expertise to a New University-Based CRO
Provided Clinical Data Management expertise to a new university-based Clinical Research Organization. Created data management and EDC-related SOPs. Coordinated data management of multi-center breast cancer study. Provided guidance on implementation, configuration, and feature changes for new EDC system. Created analysis files from database exports using SAS programming. Managed Computer Validation Project (Clintrial Version Upgrade)
Managed Computer Validation Project – Clintrial Version Upgrade (August 1999 to February 2000)
Managed validation of upgrade of a unix-based installation of Clintrial for Biometrics department of a small biotechnology company. Revised all SOPs and Working Procedures for Biometrics and CDM departments. Created a Master Validation Plan and procedures for SAS programming activities for Biometrics department.
Managed Computer Validation Project – Argus Safety New Installation (November 2000 to March 2001)
Managed configuration and validation of Argus Safety for the new Pharmacovigilance department of a biotechnology company that had just received FDA approval of their first marketed product.