Ashley Duncan-Pusey

IQVIA,U.S Remote                                                                                                     June 2021 – Present

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Associate Clinical Lead (External Development Operations Supplier Lead IRT for Novartis)

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• Fulfilling a central role within the CTT, the EDO Supplier Lead provides a single point of contact (SPOC) for supplier services at a trial level and is the first point for issue escalation during study start up, acting as a conduit for clear communication and robust daily oversight.

• Contributes to trial level milestones related to supplier deliverable/performance such as submission deadlines, FPFV milestones or other service-related targets.

• Contributes to trial timelines by managing supplier’s delivery performance.

• Documented supplier oversight and robust issue escalation. Supplier’s trial level KPI/KQI performance.

• Participates in decision making sessions with other key internal partners and collaborates successfully with key internal/external key partners.

• Defines and shares best practices and standards for cross-divisional operations within EDO.

• Demonstrates excellent working relationships with Suppliers, Procurement, Quality, and CTT.

• Preform quality supplier set up for study start up services. Excellent knowledge of GxP and ICH regulations.

• Expert knowledge of clinical trial design and mapping to supplier requirements. Thorough and technical understanding of specifications for supplier provided services.

 

Signant Health, Trevose, PA   

Apr 2017 - May 2021

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Associate Project Manager (RTSM/IRT/IWRS)     

Aug 2019 – Present

                                                                                                                   

• Manage all phases of each assigned project, from scoping through close-out.

• Manage all aspects of projects including budget, invoicing, staffing, project plan and client deliverables. Manage multiple projects concurrently, maintaining project schedule and quality deliverables within a dynamic global environment.

• Provide recurring project status reporting and ensure proper escalation.

• Ensure both timely and quality preparation of project deliverables based on assigned scope-of-services; Oversee development and approval of study materials.

• Coordinate with internal departments and subject matter experts for clinical and technical deliverables across global locations.

• Adhere to Total Quality Management requirements including SOP. Development, configuration, testing and implementation of proprietor technical solutions including UAT. Manage and maintain study hardware and documents.

• Facilitate data management deliverables. Deliverables may include: Data Management Plan, Data Transfer Specifications, Data Reporting and Analytics, and in support of additional study related-items.

• Track monthly and quarterly metrics and provide regular reporting metrics to Senior Management.

• Coordinate the transition of the IRT study configuration from the testing environment to production environment.

• Manage scope change, development and processing of change orders including socialization for assigned projects in cooperation with Business Development Operations Management of Profitability, Utilization and Allocation for assigned projects.

• Manage identification and resolution of clinical trial data inquiries/data changes and communication to internal and external multi-function resources within project teams. Manage communications with client e.g. pharmaceutical sponsor, CRO and site personnel regarding site/study details.

• Train and support site personnel and study team on technical platforms.
  Develop and maintain strong client relationships including routine written, verbal and face-to-face communication.

• Competency and expertise to provide oversight on all tasks completed by project team members.

 

Project Specialist (RTSM/IRT/IWRS)                                              

Apr 2018 – Aug 2019

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• Manage delegated project activities to ensure the timely and quality preparation of project deliverables based on scope-of-services.

• Manage and maintain communications with clients (e.g. pharmaceutical sponsor, CRO) and site personnel throughout the entirety of the Project Lifecycle from study start to study closedown.

• Liaise with internal project team regarding project deliverables, such as monitor timelines and quality, provide status updates to Project Manager and escalate risks and issues to the Project Manager.

• Prepare study materials such as data transfer documentation, questionnaires, training materials, equipment order forms, study closedown materials, and various other documents as required.

• Perform identification and resolution of clinical trial data inquiries, data changes, and communication to internal and external multi-function resources within project teams.

• Produce data reports (e.g., weekly, interim, final, etc.) for submission to clients.

• Attend training events (e.g. Investigator’s Meetings, Phase I site staff training) and facilitate training sessions (requires occasional overnight domestic and international travel).

• Attend training events (e.g. Investigator’s Meetings, Phase I site staff training) and facilitate training sessions.

   

Senior Project Assistant                                                                 

Jan 2018 – Apr 2018

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• Facilitate study materials creation, reproduction and distribution for start-up, execution and analysis activities.

• Assist with deployment/event support (system launches, ARS, audio/visual, trainer toolkits, Webcast setup, etc.) as necessary.

• Monitor assigned systems for data submission and processing.

• Administrative duties include: word processing, mail merge, copying, scanning, collating, filing, faxing, package shipping including customs management, confirmation of receipt, and tracking.

• Assist with study system setup and configuration as assigned.

• Mark and/or enter data for rater/site submissions into proprietary enterprise application (e.g. RDA, IR2, CDR Prism, etc.).

• Perform data quality control activities for assigned projects.

• Communicate with site/study personnel via phone, fax and email.

• Proactively identify task issues and escalate as necessary to team management.

• Assist with audit preparations and project reconciliations as necessary.

• Assist with IT validation testing as required.

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Project Assistant                                                                            

Apr 2017 - Dec 2017

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• Assist with study materials creation along with reproduction and distribution.

• Communicate with site/study personnel via phone, fax, email, etc. as assigned.

• Monitor assigned systems for data submission and processing.

• Administrative duties include: word processing, mail merge, copying, scanning, collating, filing, faxing, package shipping, confirmation of receipt, and tracking.

• Assist with study system setup and configuration as assigned.

• Mark and/or enter data for rater/site submissions into proprietary enterprise application (e.g. RDA, IR2, CDR Prism, etc.)

• Perform data quality control activities as outlined for assigned projects .