Experience

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  Icon clinical research

  Jan 2003 - Apr 2013

  • Acted as the functional lead from clinical operations with oversight of, and overall accountability for site selection; site start up (including submissions and Investigator contract negotiation); patient recruitment; site monitoring; data retrieval and study close-out. • Primary point of contact for Clinical Operations aspects of designated projects and responsible for developing successful working relationships with clients• Overall responsibility for managing the clinical operations project team and ensuring compliance with ICON SOPs, study contracts, budgets and quality standards.• Responsible for planning, scheduling and implementing the Clinical Operations aspects of projects• Responsible for risk mitigation strategies, associated action plan and issue resolution, and contributions to the cross-functional project management plans. • Responsible for managing the Clinical Operations project team (CRAs and CTAs), including ensuring all necessary project training and mentoring are provided to assigned staff• Managed external vendors• Actively involved in bid defense meetings• Proactively communicated any changes in Clinical Operations scope to the Finance Department• Collaborated with Business Development (BD) to ensure timely completion of change orders• Tracked Clinical Operations project deliverables using appropriate tools• Effectively monitored and reported on progress of the Clinical Operations aspects of projects to all stakeholders• Supervised GSS staff in performance of their day to day work, including management of resource allocations• Implemented QC activities as necessary and monitored required quality metrics• Line management of Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs) Show less

  • Project Manager, Clinical Operations

    Jun 2006 - Apr 2013

  • CRA/Lead CRA

    Jan 2003 - Jun 2006
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  Covance

  May 2013 - Apr 2021

  Senior start up project manager

  • As required, fulfill the role of start-up manager and oversee coordination of study activation components of the project from an oversight level including Feasibility, Site selection, Site Activation, Labels/Supply, Regulatory Submission, IP approval, Site Initiation visit and site readiness• Delivery of the start-up component of assigned studies within the region (defined as all activities required to initiate all study sites as per study planning). Including accountability for delivery to time, budget and quality• Serve as primary liaison between start up team and operational project teams or assign relevant start up member staff to carry out this function• Primary point of contact for Study Start up aspects of designated projects and responsible for developing successful working relationships with clients• Management of start up portion of project budgets, including input into preparation of utilization reports (projected and actual) and implement measures to ensure accurate billing• Assess workload and staffing needs of group (resource allocation)• Present at internal and external meetings including client meetings• Create required project plans. Implement and monitor progress against project plans and revise as necessary. Responsible for appropriate issue escalation• Direct line management responsibility for start up team members• Mentorship/Line Management of Start Up PM Show less

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  Labcorp drug development

  May 2021 - Jun 2023

  Project director, start up

  • Leadership and support to direct reports during study start-up and maintenance• Delivers visible leadership for clients both internally and externally through effective problem solving• Ensure team alignment to client expectations at a project and portfolio level, representing start up to clients at a portfolio governance level• Serve as an escalation point and resolve conflicts, as needed• Initiate improvements to enhance the efficiency and the quality of the work within site activation and maintenance. Lead and support successful implementation of initiatives• Contribute to proposal strategy, development, costing, and bid defense for assigned business development opportunities• Lead internal Project Review meetings to monitor if site activations are on track. Ensure project risks are discussed. Provide ongoing oversight to ensure mitigation plans are in place and working for any projects off track or at risk for becoming off track Show less

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  Fortrea

  May 2023 - now

  Project director, start up

  • Leadership and support to direct reports during study start-up and maintenance• Delivers visible leadership for clients both internally and externally through effective problem solving• Ensure team alignment to client expectations at a project and portfolio level, representing start up to clients at a portfolio governance level• Serve as an escalation point and resolve conflicts, as needed• Initiate improvements to enhance the efficiency and the quality of the work within site activation and maintenance. Lead and support successful implementation of initiatives• Contribute to proposal strategy, development, costing, and bid defense for assigned business development opportunities• Lead internal Project Review meetings to monitor if site activations are on track. Ensure project risks are discussed. Provide ongoing oversight to ensure mitigation plans are in place and working for any projects off track or at risk for becoming off track Show less