Amy Poplin Email & Phone Number

Wilmington, Nc, Us

Wilmington, North Carolina, United States

Leader of a team of Global Analytics Analysts that derives clinical trial data to support the pre-award process of clinical trial management. Continuously seeking process improvements within the department and driving an ongoing integration through change management processes.• Responsible for direct supervisory and related functions for 11 global Associate Analysts, Analyst Is, Analyst IIs.• Serve as point of contact for issue escalation and process alignment during proposal process.• Support and/or lead departmental quality or process improvement initiatives.• Develop and revise Standard Operating Procedures when necessary.• Lead the selection and on-boarding process for new employees by conducting review and participating in the interview process. • Provide guidance on bid defense process by participating in mock BDM as a client for first time presenters within the department.• Maintains employee metrics for department to be presented to Senior Management, which include number of opportunities, turnaround times, attrition, and client deliverables.

Wilmington, North Carolina, United States

• Responsible for direct supervisory and related functions for Associate Support Analysts, Mid-level Support Analysts and Senior Support Analyst, which include career development, training, and performance management.• Lead the selection and on-boarding process for new employees by conducting review and participating in the interview process. • Part of a Management Team that maintains project resourcing for 23 Team Lead/Senior/Mid-Level/Associate Support Analysts to ensure adequate coverage to support the current IRT systems in production. While also maintaining utilization targets and forecasting accuracy. • Monitors Support metrics to ensure communicated processing times are being adhered to for client and/or clinical team study requests. As well as monitoring study specific trends.• Create/Update departmental guidance documents while looking for areas of improved efficiencies.• Review/Approve outsourced IRT UAT test scripts.• Perform lead investigator tasks for a cross-functional team related to internal IRT CAPAs while utilizing internal Quality Management System (QMS).

Wilmington, North Carolina Area

• Responsible for direct supervisory and related functions for Quality Analysts/Senior Quality Analysts, which include career development, training and performance management.• Part of a Management Team that maintains project resourcing for 15 Senior/Mid-Level Quality Analysts to ensure timelines are met within budget constraints and utilization is within target.• Perform and/or oversee special project validations such as PPD designated tier 4 computer systems validations.• Perform review/approval of system validation test cases and data setup for mid-level and Senior Quality Analysts. •Perform detailed internal audits and review of study specific IRT validation and change control documentation to confirm consistency, accuracy, and compliance to PPD-approved procedures.• Host study specific and capabilities audits on behalf of the IRT Department.• Perform lead investigator tasks for a cross-functional team related to internal IRT CAPAs while utilizing internal QMS.• Develop and revise Standard Operating Procedures when necessary.• Conduct Production Readiness Reviews prior to system release into production.• Create and Implement Process Improvement initiatives within the entire IRT department.• Create/Update departmental guidance documents and/or manual testing templates.

Wilmington, North Carolina Area

• Perform IRT / Interface validation documentation including writing and executing test scripts based on system design specifications.• Load/Update study data within testing database system utilizing SQL and manual manipulation.• Provide review of system design specifications prior to build to ensure validity.• Perform review/approval of test cases for mid-level and other Senior Quality Analysts.• Provide guidance on testing and departmental objectives.• Conduct Production Readiness Reviews prior to system release into production.• Train staff on any new or existing processes.• Perform routine auditing functions ensuring that the IRT department is operating in compliance with PPD approved procedures as well as current FDA regulations (21 CFR Part 11).• Perform special project validations such as PPD designated tier 4 computer systems validations.• Create/Update departmental guidance documents and/or manual testing templates.

Wilmington, North Carolina Area

• Perform IRT / Interface validation documentation including writing and executing test scripts based on system design specifications.• Load/Update study data within testing database system utilizing SQL and manual manipulation.• Provide review of system design specifications prior to build to ensure validity.• Perform document management functions including but not limited to: document review, organization and archiving• Perform routine auditing functions ensuring that the IRT department is operating in compliance with PPD approved procedures as well as current FDA regulations (21 CFR Part 11)

Wilmington, North Carolina Area

• Processed Engineering design specifications with use of in-house software• Tested in-house software of compliance with current building codes• Provided technical information to building officials, distributors and other inquiries• Assisted R&D Manager in code evaluation approvals• Maintained Quality Assurance Manuals for all North American manufacturing facilities• Processed payments for code agencies and third party inspection agencies

Wilmington, North Carolina Area

• Assisted R&D Manager in code evaluation approvals• Maintained Quality Assurance Manuals for all North American manufacturing facilities• Processed payments for code agencies and third party inspection agencies