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•Forecast and identify opportunities to accelerate activities to bring revenue forward•Identify changes in scope and manage change control process •Identify lessons learned and implement best practices•Drive successful data cleaning in close collaboration with Data Management

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•Assist with forecasting and budget for clinical studies •Attends financial review meetings to assist with reconciliation and identification of budget over burn across functional areas•Oversight of development and implementation of project plans.•Analyze study risks and issues and coordinate monthly reviews•Implement mitigation strategies to ensure successful delivery of project goals•Provides project-specific training to internal and external audiences as required•Train and mentor internal team members•Implement job aids for study team members •Plan, coordinate and present at internal and external meetings•Acts as primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and the Company's contractual agreement•Perform line management responsibilities for the recruitment, training, utilization, development and performance review of assigned staff

•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)•Maintain and monitor model projections for study enrollment metrics to ensure the studies remain within the timelines for enrollment and LPO•Monitor and report ROI metrics for patient recruitment activities •Ensure all vendor supplies are on site for site activation •Complete monthly billing tracker for sponsor invoicing •Serve as the Clinical Trials.gov point of contact •Process and track vendor invoices, site invoices, and investigator grants payments •Reconcile multi-million-dollar site grant payments for over and underpayments from third party vendor •Cross check study budget for applicable SOPs based on scope of work requested by sponsor company

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•Scheduling, prepare and distribution of meeting agendas, minutes and action item logs•Manage and mentor Project Specialists•Train new employees assigned to project• Company mentor for new Project Specialists assigned to different studies•US company team trainer of new Project Specialist across therapeutic business units •Conduct Project Specialist interviews resulting in the hire of skilled Project Specialists in the CNS Business Unit

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 •Point person for Quality Control for the Project Management Team•Signing authority for approval letters •Business Resumption Plan Test Lead •Served as an ISO Auditor (Internal Organization for Standardization)•Kaizen Team Member- Streamlined company processes

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•Processed study level and site level submissions for IRB approval

•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