Tabata Fiorillo Dálio
Associate Regulatory and Start Up Manager | Associate Site Activation Manager at IQVIA- Claim this Profile
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Espanhol Limited working proficiency
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Inglês Full professional proficiency
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Português Native or bilingual proficiency
Topline Score
Bio
Credentials
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Leading Global Innovation - Illinois Tech and FIA
Illinois Institute of TechnologyJun, 2023- Sep, 2024 -
CRF
Conselho Regional de Farmácia do Estado de São PauloJan, 2019- Sep, 2024
Experience
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IQVIA
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United States
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Hospitals and Health Care
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700 & Above Employee
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Associate Regulatory and Start Up Manager | Associate Site Activation Manager
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Aug 2022 - Present
Oversee the execution of Site Activation (including pre-award/bid defense activities) and/or Maintenance for assigned projects in accordance with the agreed site activation strategy, adhering to project timelines. Develop, implement and maintain the Site Activation Management Plan according to the Scope of Work and Project Plan, within the agreed project strategy, resolving project related issues. Communication with regions and countries, to successfully deliver the agreed project scope in compliance with the Management Plan. Create and/or review technical and administrative documentation to support business development and enable study initiation and maintenance. Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements. Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start-up and maintenance phase as an integral member of the study management team. Determine regulatory strategy and parameters for submissions; and offer creative and practical solutions to support the bid process. Assess and review the regulatory landscape and contribute to the collection, interpretation, analysis and dissemination of accurate regulatory intelligence to support assigned studies and wider company.Execute operational strategy for maintenance of clinical study approvals, authorizations and review/ negotiation of contracts and essential documents. Mentor and coach colleagues.Ensure accurate completion and maintenance of internal systems, databases, tracking tools, timelines and project plans with project specific information. Take a lead role in developing long standing relationships with preferred IQVIA customers. Deliver presentations/training to clients, colleagues and professional bodies. Involved in activities related to monthly study budget planning and reviews. Show less
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Project Management Analyst
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Jun 2021 - Jul 2022
- Monitor and control project performance and communicate to internal stakeholders- Direct and coordinate project planning, scheduling and project finances- Ensure effective reporting of cost, schedule, scope, utilization and change orders- Perform risk management (identification, assessment and management of project risks)- Meet quality standards and metrics during the course of the project through quality control procedures- Ensure compliance with operating procedures, work instructions, project scope of work and applicable regulatory requirements- Develop and manage the ‘Project Execution Plan’ sections related to project tracking, trending, reporting and change control Show less
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DRS GROUP
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Germany
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Motor Vehicle Manufacturing
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1 - 100 Employee
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Commercial Executive – Key Accounts Clients
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May 2020 - May 2021
Activities:- Project management in conjunction with internal teams and client;- Negotiations and sales management;- Responsible for preparing commercial proposals and contracts through the project scope requested by the client;- Communication with all internal areas for the preparation of commercial proposals and pricing of services;- Ensuring business sustainability by attracting and maintaining large account customers;- Responsible for external service, identifying needs and proposing solutions compatible with the reality of the group's customers;- Attract new customers and identify opportunities for expanding services to customers already served;- Establishing a relationship of trust and respect with the customer, through the monitoring of sales processes and, at times, acting as a mediator of commercial relations between the company and the person responsible for carrying out certain services;- Prepare customer follow-up reports;- Analysis of strategic indicators, monitoring competition, identifying solutions, and / or proposing strategic actions;- Knowledge of clinical research, post-studies, patient support programs, SAC and health technology;- Knowledge of regulatory affairs.Achievement to highlight:- Participating in promotions and internal meetings, implementing innovations and technology;- Customization of services and projects according to each client. Show less
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Operational Pharmacist Júnior
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Mar 2019 - May 2020
Activities:- Responsible for the prevention and verification of tax divergences and product breakdowns, with the aim of ensuring the arrival to the consumer in perfect condition;- Physical and documentary checking of medicines and supplies for clinical research and post-studies, imported, stored, and distributed by the company;- Participation in the analysis of the labeling of some medications and supplies, whenever requested by the customer, in order not to hide any information in their packaging;- Responsible for the decisions of places and temperatures for storage of products, aiming to guarantee their effectiveness;- Development of flow improvements in the storage area, aiming to meet high demands;- Definition of space optimization.Achievement to highlight:- Participant in commissions and internal meetings, helping to improve operational flow, sustainability, and cost reduction of services. Show less
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Sírio Libanês Hospital
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Brazil
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Medical Practices
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1 - 100 Employee
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Administrative Intern - Pharmacy
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Dec 2017 - Dec 2018
Activities: - Monitoring of the sector's surveillance area (Pharmacovigilance and Tecnovigilance), to notify authorities and contact with suppliers to reduce misuse, offer training, and mitigate manufacturing or storage errors by third parties; - Study to search for substitutes for hospital supplies and standardized drugs that are lacking in the national market, minimizing the depletion of internal stock; - Consult official information (Official Gazette and ANVISA) to make stockpiles and disseminate correct information on uses; - Application of internal educational training at the institution; - Advisory guidance on clinical, system or logistical inquiries for health professionals, internal and external, and patients. Achievement to highlight: - Participant in the Therapeutic Pharmacy and Material Standardization commissions, helping to reduce costs and products in unused stock, in addition to adapting internal processes and resolving complications. Show less
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Universidade Estadual de Campinas
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Brazil
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Research Services
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700 & Above Employee
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Programa de Apoio Didático (PAD)
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Aug 2017 - Dec 2017
Teacher's teaching aid in biochemistry Application of practical classes Teacher's teaching aid in biochemistry Application of practical classes
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FAPESP Research Fellow
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Jan 2016 - Dec 2017
Metabolomic analysis of Trypanosoma cruzi isolates from patients with different clinical forms of Chagas disease using laboratory techniques and drugs to identify new treatments and parasite biosignalization. Preparation of scientific article. Metabolomic analysis of Trypanosoma cruzi isolates from patients with different clinical forms of Chagas disease using laboratory techniques and drugs to identify new treatments and parasite biosignalization. Preparation of scientific article.
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Hospital de Clínicas - UNICAMP
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Health, Wellness & Fitness
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200 - 300 Employee
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Intern
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Jul 2017 - Aug 2017
Drug dispensation for hospitalized patients; Monitoring of patient adverse reactions and technical problems of hospital supplies for notification to authorities and risk mitigation; Controlled psychoactive use reducing improper use; Assist the processes of choosing manufacturers and distributors reducing costs. Drug dispensation for hospitalized patients; Monitoring of patient adverse reactions and technical problems of hospital supplies for notification to authorities and risk mitigation; Controlled psychoactive use reducing improper use; Assist the processes of choosing manufacturers and distributors reducing costs.
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Education
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2023 - 2024
fia.com.br
Master of Business Administration - MBA, Business Administration and Management, General -
2014 - 2018
Universidade Estadual de Campinas
Ensino superior completo, Farmácia -
2019 - 2020
Fundação Getulio Vargas
Post-graduated, Post-graduated in Business Administration and People Management -
2021 - 2021
INVITARE
Professional Development Course in Clinical Research, Clinical Research
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