Caroline Vanso

Experience

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  Merck Sharp & Dohme

  Sept 2003 - Nov 2004

  Trainee
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  Drogão - Drugstore

  Apr 2005 - Oct 2006

  Responsible Pharmacist
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  Intrials Clinical Research

  Oct 2006 - Sept 2018

  Core Responsibilities:All project management aspects including:- Key contact between sponsor and internal team.- Study financial revenue recognition.- Study metrics/milestones control/ report.- Study meetings management (organization, presentation, attendance).- Study staff training and mentoring including co-monitoring visits, trainings, support (Acting as a Line Manager).- Employees’ monthly meeting and individual evaluation.- Study documents review/implementation (guidelines, procedures, reports)- Audit/Inspection preparation (documents review, staff training, CAPA implementation).- Therapeutic Areas: Bioequivalence, cardiology (ischemic heart disease), dentistry, genetics (gaucher disease, MPS), infectious disease, oncology (esophagus, head and neck, lung), otorhinolaryngology (flu).Important Achievements:- Revenue recognition organization (backlog resolution);- General project backlog resolution (monitoring activities, events management);- Staff training/ mentoring improvement (evidenced by quality of reports and study issues resolution). Show less Core Responsibilities:- Responsible for Quality System implementation, including: Standard Operating Procedures (SOP)s, Guidelines (GUI)s, Policies (POL)s and Form Templates (FT)s elaboration, review and implementation.- Intrials’ staff training management and mentoring, including performance evaluation.- Host inspections and audits, finding resolution (CAPA) management.- Internal CAPA management.- Internal vendors management.- Perform audits to investigative sites, Intrials offices, internal processes, vendors.- Company systems implementation responsible (CTMS, GCP training, online server).- Study documents review, including medical writing activities.- Study meetings participation (staff training, documents review, procedures creation).- Clinical Operations staff selection process (Interviews, test application/correction).- New employees’ company integration process.- Employees’ company termination procedures (E.g. handover activities, termination interview).- Metrics/Milestones development with the clinical operations team. Important Achievements:- Inspections and sponsor audits (more than 15) with no critical findings and all CAPAs successfully implemented/closed.- Vendor Qualification Process/Vendor Management activities implementation and execution.- Online server implementation.- TMF, standard monitoring tools, study metrics control implementation. Show less Lead Clinical Research Associate Sep/13 – Mar/14Senior Clinical Research Associate Jul/11 – Aug/13Clinical Research Associate Oct/07 – Jun/11Regulatory Affairs Assistant Oct/06 – Oct/07- Therapeutic Areas: Cardiology (Stenosis), genetics (Gaucher Disease), gynecology (HPV), oncology (Lung, esophagus), otorhinolaryngology (Flu), respiratory (Asthma) and urology (BPH).- Phase studies: II, III and IVCore Responsibilities:- Study conduction, coordination and management from feasibility, Site Selection to Close Out as a Project Leader.- Milestones and metrics management with the study team.- Quality control implementation during all study conduction (tolls, rules).- Sites management (Including site recruitment strategies).- Site staff training, clients/ internal training: Clinical trials matters, protocol specific procedure or SOPs.- Regulatory submission/control/management for regulatory agencies (EC, ANVISA – Brazilian MoH).- Safeties reports control (translation, review, sites shipment, submission track).Important Achievements:- Sponsor audit conduction with no critical findings and CAPA successfully implemented/closed.- Based internally and also outsourced in two global pharmaceutical companies.- Experience with vaccine trials learning the logistics of a big trial, implemented a tracking tool for TMF.- Experience in a rare diseases trial with multiple vendors (central labs, central image readings). Show less

  • Clinical Research Project Manager

    Mar 2014 - Sept 2018

  • QA and Training Manager - Clinical Operations

    Sept 2013 - Sept 2018

  • Clinical Research Associate

    Oct 2007 - Mar 2014

  • Regulatory Affairs Assistant

    Oct 2006 - Oct 2007
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  IQVIA

  Sept 2018 - Jan 2021

  Clinical Lead
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  PPD

  Jan 2021 - Jul 2021

  Senior Clinical Team Manager
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  ICON Strategic Solutions

  Aug 2021 - now

  Clinical Trial Project Manager