Olivia Lindsey

Serve as both eCOA Project Manager and eCOA Application Specialist/UAT Lead for 40+ long-term, actively enrolling clinical trials (Phase II and III) within a 4 year time period and 75+ system releases (initial and post go-live)

• Developed instructional materials and led multiple UAT training and onboarding sessions to the ICON eCOA/eClinical department, improving UAT knowledge, engagement, and standardization
• Collaborated with departmental leaders to identify staffing needs, create targeted job descriptions, and serve as a key team member for interviewing potential candidates for the UAT department
• Oriented newly hired employees by providing company information, facilitating onboarding processes and establishing position-related requirements.
• Work closely with vendor project management and clinical teams to design and develop robust solutions to meet client requirements for functionality, scalability and performance
• Author and manage UAT documentation – UAT Test Plan and Summary reports, test scripts, defect tracker, and UAT release reports
• Implement user acceptance testing with focus on documenting defects, identifying bottlenecks and executing test cases

Deliver project management and technical expertise for the utilization of eCOA instruments within clinical trials.

• Serve as both eCOA Lead and UAT Lead for 10 long-term, actively enrolling clinical trials (Phase II and III) within a 2 year time period
• 100% success rate of milestones and deliverables for all assigned studies
• Work closely with vendor project management and clinical teams to design and develop robust solutions to meet client requirements for functionality, scalability and performance
• Author and manage UAT documentation – UAT Test Plan and Summary reports, test scripts, defect tracker, and UAT release reports
• Implement user acceptance testing with focus on documenting defects, identifying bottlenecks and executing test cases

Generates and manages OQ and PQ Validation Packages, including but not limited to, Validation Plans, Test Plans, Trace Matrices, Test Scripts, Test Cases, Test Summaries, Validation Summaries, and System Change Control documentation for multiple eCOA platforms to meet the unique needs of several clinical trials.

• Coordinates and documents the validation packaging for over 4 major proprietary tools (Windows and Apple). This includes over 50 change requests and 20+ iOS validations within a 2 year period.
• Assists with the preparation and completion of Sponsor audits or regulatory inspections. This has led to the successful completion of over 11 Sponsor audits with little to no audit findings on all Validation Documentation created to date for all tools developed in-house.
• Works closely with the VP of QA and Compliance, VP of Software Development and Product Manager to identify validation needs, process improvements, and corrective action plans
• Recommends automation of test cases for eCOA tools, which would reduce testing time by at least 25 percent.
• Provides technical leadership training and mentorship to junior and on-boarding team members on department processes and procedures, test plan/test case creation, and defect management.

Primary representative for company's software validation department and manager of all OQ and PQ Validation packaging

• Assists with the preparation and completion of over 11 Sponsor audits or regulatory inspections
• Assists with the completion of internal system audits to determine the level of compliance with applicable regulations
• Works closely with the VP of QA and Compliance, VP of Software Development and Product Manager to monitor company-wide process improvement and corrective action planning

Provides support in study specific data management including data review and verification, rater error tracking, and score reports.

• Identified to join the project team of one of the two largest studies within the company immediately after hire.
• Assesses rater qualifications for certification on cognitive batteries, discerning assessment administration and scoring competence.
• Supports Project Leads with study start-up, maintenance, and closeout processes