Fernanda Tizzot

Experience

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  Elo Apoio Social e Ambiental

  Feb 2006 - Apr 2007

  Intern

  Elo is a nongovernmental organization that develops social projects and provides services regarding social and environmental responsibility. Part of the sustainability of the organization comes from the services provided by the environmental area.Main activities:- Activities regarding waste management and environmental law- Preparation and control of solid waste management plans in industries- Participation in environmental management system audits as auditor in training

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  Petrobras

  Apr 2007 - Mar 2008

  Intern

  Intern at the Environmental, Health and Safety Department.Main activities:- Solid waste management and pollution control- Responsible for maintaining and adequacy of the solid waste management plan- Responsible for the compilation of information regarding air emissions monitoring

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  Ministério Público do Estado do Paraná

  May 2008 - Sept 2009

  Intern

  Intern at the Operational and Technical Support Department.Main activities: - Analysis of claims and lawsuits regarding solid wastes, atmospheric, water and soil pollution- Participation in public hearings regarding the destination and recycling of solid waste- Visits in potential polluting areas/companies

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  Instituto Tecnológico Industrial Foundation (FUNDACEN)

  Feb 2009 - Jul 2010

  Professor

  FUNDACEN is a school of professional and technical education focused on developing industry professionals.Main activities:- Professor of “Sustainable Development”, “Air Quality”, “Applied Chemistry” and “Analytical Chemistry” for Technical Courses of Chemistry and Environmental Sciences- Evaluation of end-of-course papers and presentations

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  Polícia Científica do Paraná

  Sept 2009 - Mar 2012

  Forensic Toxicologist

  Forensic Scientist at the Toxicology Laboratory of the Institute of Legal Medicine of Curitiba.Main activities:- Responsible for forensic analysis in apprehended drugs and medication - Research of licit and illicit substances in biological samples- Responsible for the development and implementation of standard operating procedures (SOP’s) - President of the commission responsible for health waste management - Participation in the Brazilian Association of Technical Normalization – ABNT/CEE-137 – Normalization on the field of Forensic Science – Group of Forensic Chemistry and Toxicology Show less

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  Hospital Santa Casa de Curitiba

  Mar 2010 - Mar 2012

  Clinical Research Coordinator

  Key Responsibilities:- Conduct the daily execution of clinical research protocols, including, but not limited to, obtaining informed consent, completing study procedures, dispensing and accounting for investigational products- Obtain/maintain ethical approval for studies- Report to central and local IRB - Assists in performing appropriate research protocol procedures such as: vital signs, pregnancy tests, blood collection and processing, ECGs, body measurements and pain assessments- Assist the PI in the recruitment of prospective research subjects- Development of materials and tools necessary to guarantee subject retention and adherence- Entry data in electronic and paper clinical research forms and solve eventual queriesTherapeutic areas: diabetes and cardiology Show less

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  Aché Laboratórios

  Mar 2012 - Jul 2015

  Clinical Research Associate

  Key Responsibilities:- Monitoring activities in phase I, III and IV trials- Prepare and/or participate in Investigator’s Meetings and trainings related to the study- Implement and monitor clinical trials to ensure sponsor/investigator obligations are met and are compliant with applicable local regulation- Assist in investigator study site selection and study start-up- Conduct pre-trial, initiation, monitoring and close-out visits- Monitor study sites to confirm protocol compliance, assess qualifications of study personnel and ensure Good Clinical Practice- Identify site issues and initiate correction plans based on monitoring reports- Assure that all the study files are organized and updated- Check data against source documents, initiate data query resolution and confirm resolution in timely manner- Ensure subject safety and adverse event reporting to sponsor and ethics committee- Participate in the process of requesting medication and reconciliation- Supervise, assure and keep control of clinical supplies and investigational products on study sites- Provide study status updates to team members and project manager, including interaction to resolve site issues and facilitate project timelines- Assist in project management of trials conducted by CROs- Collaborate in the elaboration of clinical trial documents such as, but not limited to, study protocols, informed consent forms, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reportsIndications: Epilepsy, Migraine, Lipid Metabolism Disorders, Cardiovascular Disease, Asthma, Diarrhea, Anti-inflammatory Drugs Show less

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  IQVIA

  Feb 2016 - Nov 2023

  Key Responsibilities:- Planning and executing the Quality Management activities- Risk identification and assessment through data review and quality control processes either remote or on site- Providing support in risk mitigation, in planning corrective/preventive actions and guidance for improvement- Supporting the assigned business line management and staff to enhance effectiveness of Site Visits conducted by them- Cooperate closely with the relevant Heads of business and other stakeholders, support maintaining focus on quality in project delivery- Contribute to the development and implementation of a Quality Management Plan and Risk Management Program, monitor the implementation and delivery- Provide advice and support to operational teams within the assigned business line, including Clinical Research Associates, Line/Site Network Managers, Resource Managers and other key stakeholders on all aspects of GCP compliance- Work in close cooperation with operational teams to manage non-compliance, quality issues; assist in planning corrective/preventive actions- Work closely with Quality Assurance and assigned business staff in case of suspected misconduct- May provide assistance during audits and regulatory inspections to the operational teams - Act as the primary contact for Quality Assurance on clinical quality matters- Prepare periodic reports to Heads of Quality Management and to stakeholders on quality related matters, risk assessments and specific quality improvement initiatives Show less Key Responsibilities:- Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice- Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager- Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation- Act as a mentor for new clinical staff- Provide assistance to the Clinical Project Manager and/or CRS with design of study tools, documents and processes Show less

  • Quality Manager, Global Site Management

    Sept 2021 - Nov 2023

  • Clinical Operations Quality Specialist / Senior Quality Specialist

    Dec 2017 - Aug 2021

  • Senior Clinical Research Associate

    Feb 2016 - Dec 2017
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  Merck

  Dec 2023 - now

  Assoc. Dir, Clinical Research, Country Clinical Quality Manager (CCQM)