Ingrid Guandaligni

Experience

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  Instituto Brasileiro de Controle do Câncer - IBCC

  Apr 2005 - Apr 2008

  Research Nurse / Chemotherapy

  • Acted as a Research Nurse of 20+ Oncological and Gynecological Global Clinical Trials, phases II - IV.• Managed a team of Assistant Nurses.• Supported the implementation and management of the Institution’s Tumor Bank.

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  Clínica La Vue Oftalmologia

  Dec 2006 - Apr 2008

  Auditor Nurse

  • Executed financial audit of surgeries and medical procedures conducted by local staff.• Supervised extracurricular trainee programs in Nursing.

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  Spedali Civili Brescia

  Jun 2008 - May 2009

  Clinical Medicine Nurse

  • Assisted patients requiring hospital stay.

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  Azienda Ospedaliera San Gerardo

  May 2009 - Aug 2011

  Neonatal Intensive Care Nurse

  • Developed and implemented a Risk Management project inside the NICU with the aim of improving technology and reducing the risk associated to drug administration [published work on Ped. Med. Chir. (Med. Surg. Ped.), 33, p.31].• Provided critical assistance to premature neonates and delivery room stabilization of high risk newborns.

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  Parexel

  Aug 2011 - Nov 2021

  • Provided overall leadership of global clinical trials as well as cross-functional project teams to achieve operational excellence and deliver projects on time, to budget, with first-time quality, compliant with ICH GCP, and that exceeds client expectations. • Led project teams and Client teams to progress best solutions securing good relationship, with business understanding to independently make effective decisions translate into actions, performing ongoing risk management. • Responsible for the profitability of small to midsize projects and client satisfaction, acting as a role model for the team. Show less • Acted as Associate Project Leader for phase I/II and III clinical trials since July 2015, and as Global Project Leader since December 2017 for phase III trials. • Sponsor liaison, project assessment and initiation, financial management, resource procurement and planning, and project implementation. Led and motivated global cross-functional teams and conducted milestone planning and tracking through delivery on time. Project closeout activities, budget reconciliation and TMF transfer. • Guaranteed project progressed according to quality standards, SOPs, ICH-GCP and other guidelines to fulfill local regulations.• Managed external vendors, produced key project progress reports and managed communication between Parexel project teams and Sponsor, securing Clinical alignment at the program level. Show less • Worked with the Company’s Strategic Partnership Infrastructure team as a core team member and Subject Matter Expert to ensure appropriate operational delivery, managing compliance, guaranteeing systems maintenance and correct closure by working with individual study teams.• Led the partnership metrics work stream pillar to drive successful implementation of a new Outsourcing Model as the owner of study outsourcing processes, identifying, driving and creating improvement, guaranteeing proper deployment and smooth transition for study teams. This includes developing trainings in accordance with the sponsor needs and coaching internal and external teams.• Led the initiative responsible for improvement of overall clinical compliance metrics at the partnership level and project level. Supported training of Project Planning, Global Clinical and Leadership teams to ensure proper comprehension of metrics definitions which were reflected in improved numbers. Executed deeper data analysis of study status, improving engagement of different study teams.• Supported the implementation of technology transfer projects (CTMS, TMF, project management information system and recruitment forecast). Show less • Defined, managed and analyzed partnership/portfolio specific performance and operational metrics. • Acted as Subject Matter Expert for Project Specialists and Project Leaders assigned to the Strategic Partnership, developing guidelines for standardization of processes and implementing initiatives, assisting project teams to ensure good adherence to newly implemented process maps.• Provided mentorship at international level to Project Specialists joining the Company. • Communicated across various levels of internal and external functions at a global level and delivered trainings as needed. • Maintained partnership wide documentation. Show less • Provided project management support to Project Leader and Functional Leaders as a team member, setup internal systems/tools/plans, guaranteeing their maintenance, executing data analysis of study status and milestones to ensure overall team compliance and on-time delivery.• Managed project resourcing and conducted project closeout activities.• Assisted study specific documents preparation and version-control for inspection readiness and supported management of study supplies on study level. • In July 2012, joined the Strategic Partnership team as a Portfolio Project Specialist. Show less

  • Project Leader

    Sept 2020 - Nov 2021

  • Project Leader

    Nov 2018 - Aug 2020

  • Associate Project Leader

    Aug 2016 - Oct 2018

  • Senior Project Specialist

    May 2014 - Jul 2016

  • Project Specialist

    Nov 2012 - Apr 2014

  • Project Assistant

    Aug 2011 - Nov 2012
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  Fortrea

  Dec 2021 - now

  Senior Project Manager

  • Accountable for project delivery with regards to agreed time, scope, cost, and quality.• Key client contact for assigned projects, establishing working relationships with client project teams to secure client satisfaction and operational excellence. Lead core project team(s), ensuring effective cross-functional teamwork among team members including both internal and external stakeholders. Serve as escalation point for project issues to internal and external stakeholders.• Understand the project delivery strategy, costing assumptions and resulting budget. Deliver project(s) remaining on track with the contract and with financial performance targets. Initiate and implement appropriate actions to proactively manage the change control process both internally and externally.• Proactively lead both quality control and risk assurance activities to ensure project deliverables are met according to regulatory, organization and client requirements.• Create and manage variance to required project plans. Per SOPs, implement and monitor progress against project plans and revise as necessary. • Aid in development and maintenance of key project performance indicators for client specified metrics, ensuring that the KPIs are within scope of the project contract. Track project progress against financial milestones using applicable financial systems.• Define and manage project resource needs and establish succession plans for key resources. Show less