Ashley J. Email & Phone Number

Raleigh, NC, US

Cambridge, MA, US

Durham, North Carolina, US

• Global Project Manager and Global Clinical Lead: Responsible for delivery and execution of regional studies
• Develop integrated study management plans with the core project team
• Collaborate with other functional groups within the company to support milestone achievement and to manage study issues and obstacles
• Monitor progress against contract/timelines
• Manage risk and contingencies proactively and lead problem solving and resolution efforts
• Ensure the financial success of the project

Morrisville, NC, US

• Manage start-up and close out of multiple vendors under aggressive timelines, including data reconciliation
• Manage and coordinate team through successful interim analyses, database snapshots and database lock
• Lead weekly Vendor calls, Internal and Sponsor calls
• Lead and monitor site activation
• Manage clinical trial staff ensuring timely completion of tasks and achieving budgetary goals
• Assess areas of need for project management change orders, as well as compile data from other study functional areas

• Allocated as Project Manager
• Coordinate with vendors on proposals for patient recruitment initiatives
• Design site communications and site materials
• Lead site engagement call with the sponsor
• Lead patient recruitment summits with sites
• Deliver slides for sponsor meetings (i.e. quarterly meetings, risk meetings)

Raleigh, North Carolina, US

• Conduct review of Essential Regulatory Documents
• Coordinate internal TMF quality review activities and serve as project representative for external TMF audits resulting in only minor findings
• Maintain sponsor portal for study sites and develop and distribute program newsletters to study team and sites to ensure clear communication regarding program updates
• Review sites status weekly to establish which sites met predetermined sponsor thresholds for possible further team review
• Deliver close out visit tools to CRAs to prepare for COVs
• Maintain study start up tracker to track completion of vital site start up activities for IP greenlight

Research Triangle Park, North Carolina, US

• Served as “back-up” to senior level colleagues
• Interviewed for the Client Services department
• Mentored and trained team members
• Updated Project Management team Job Proficiency Guides
• Oversaw Interns, coordinated training/shadowing opportunities
• Performed quality checks on team member deliverables

Research Triangle Park, North Carolina, US

• Managed approximately 98 clinical research studies and 2700 sites for physicians across the United States
• Oversaw all aspects of studies after initial approval
• Managed an additional 120 Institutional studies during senior level colleague’s transition for a five month period
• Prepared expedited submissions for Chair/Vice Chair Review and Board Members review
• Prepared packets for Full Board review
• Generated outcome documents for clients

• Designed and created company webpage
• Established and maintained professional relationships with customers.
• Demonstrated attention to detail by accurately performing office duties, including compiling a list of properties and creating and maintaining an online listings webpage.
• Exhibited professional communication, and personal presentation

• Demonstrated attention to detail by accurately performing office duties.
• Worked with associates to achieve organizational goals in a timely manner.
• Updated and changed patient/customer demographic database and inventory database
• Worked as a company representative ensuring satisfaction for both internal and external clients