Patrick Walsh Email & Phone Number

Chicago, Illinois, Us

Dublin, Ie

The role of the Manager, Project Operations is to provide leadership and effective management of a group of Analysts within the Project Operations “PO” group within the Clinical Research Planning Department. Maintain positive, strong working relationships with clients, vendors and staff.Ensure a strong group presence within ICON.Be responsible for tools, analysis & training.Attend bid defenses/selling meetings as required. Function as a key, senior level liaison for ICON with clients, as appropriate.Ensure the office and its staff operates in a professional, service-orientated and client (internal & external) orientated manner.May oversee reporting of projects to ensure they are projects conducted in a cost effective manner, meeting sponsor and expectations and in adherence with ICON KPIs & costs.Liaise with other managers, directors, VPs to improve the effectiveness of the organizationComply with ICON’s project governance system; keep senior management informed of project/departmental status in relation to payment quality, cost and timelines.Assure that appropriate plans and strategies are established and accomplished for all projects, in consultation and agreement with the study specific Project Director / Project ManagerCommunicate essential portfolio information, including resources, timelines, and budgets, for all ongoing / planned studies with Clinical Operations Senior Management and Executive ManagementFacilitate IMI Governance-level portfolio reviewsCoordinate budget review and ongoing updates to ensure financial performance and profitability Organize, lead, and oversee continuous process improvement work streams and initiativesEstablish and coordinate resource planning, management, and forecastingPromote risk mitigation and proactive resolution of anticipated problemsIdentify Project Management training needsReport monthly metrics regarding resource utilization, head count

Dublin, Ie

Responsible for assuring internal and investigator site compliance with Good Clinical Practice (GCP), relevant regulatory requirements, and Company or Sponsor Standard Operating Procedures (SOPs).

Raleigh, North Carolina, Us

Conducted and led Good Clinical Practice (GCP) audits, including investigator sites, client and Trial Master File (TMF) audits. Conducted GCP audits of vendors, databases, study reports and computer systems validation to ensure compliance with GCP regulations. Provided Quality Assurance (QA) review of draft tables and listings for study reports. Assisted with conducting QA evaluation of internal processes. Assisted in the implementation of the new Corrective Action and Preventative Action (CAPA) system to assure 21 CFR part 11 compliance. Entered audit observations into the CAPA system and monitored resolution. Performed functions as CAPA system administrator, including the granting of system access permissions to individual CAPA auditors and team members.