Daisy Machado
São Paulo
Summary
Clinical Operations Manager with over 10 years of Clinical Research Experience. Currently acting as Line Manager of CRAs and in-house CRAs based in Argentina and Peru. Strong CRO background with experience in both full-service and client-dedicated services.
Overview
13
13
years of professional experience
Work History
Manager, Clinical Operations
Fortrea
10.2022 - Current
- Accountable for performance and compliance for CRAs and in-house CRAs in LATAM (Argentina, Peru and Brazil). Oversees compliance with ICH/GCP and country regulations, Client policies, procedures and quality standards;
- Responsibilities include planning; assigning and directing work, assessing performance and guiding professional development of direct report.
- Performs quality control visits as needed to ensure patient safety and that high quality of clinical monitoring services is maintained.
- Provide oversight on monitoring activities associated with the site-level management, initiation, patient recruitment and retention, monitoring and collection of data, and closeout of clinical trial sites.
- Responsible for appropriate management and resolution of performance issues.
- Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments. Forecasts country resource needs.
- Effectively communicate management strategies, policies and procedures in conjunction with leadership teams
- Develop and maintain effective relationships with management team to manage assigned staff in a matrix environment
- Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity
- Identify, develop, and implement measures to improve the efficiency of the department.
Associate Manager, Clinical Operations
Labcorp Drug Development
10.2021 - 09.2022
- Accountable for performance and compliance for CRAs and in-house CRAs in Brazil. Oversees compliance with ICH/GCP and country regulations, Client policies, procedures and quality standards;
- Responsibilities include planning; assigning and directing work, assessing performance and guiding professional development of direct report.
- Performs quality control visits as needed to ensure patient safety and that high quality of clinical monitoring services is maintained.
- Provide oversight on monitoring activities associated with the site-level management, initiation, patient recruitment and retention, monitoring and collection of data, and closeout of clinical trial sites.
- Responsible for appropriate management and resolution of performance issues.
- Pro-actively drives/tracks execution and performance of deliverables/timelines/results to meet country commitments. Forecasts country resource needs.
- Effectively communicate management strategies, policies and procedures in conjunction with leadership teams
- Develop and maintain effective relationships with management team to manage assigned staff in a matrix environment
- Encourages use of standardized processes and tools in alignment with associated policies to ensure efficiency and productivity
- Identify, develop, and implement measures to improve the efficiency of the department.
Clinical Team Lead
Labcorp Drug Development
03.2021 - 09.2021
- Responsible for clinical project delivery with regards to agreed time, scope, cost and quality.
- Develop the strategy, plans, tools and training to oversee and assess performance of the clinical team, in the conduct and compliance of site visits (on site and remote), including, but not limited to: pre-study visits, site initiation visits, routine monitoring visit, motivational visits, close-out visits, audit support visits;
- Proactively communicate with CRAs and other members of the clinical operations team to follow up on all open issues, drive patient recruitment and retention, in order to meet the project timelines;
- Fostered staff development and competency through supervision, coaching, trainings and team meetings.
- Support/Lead Clinical project team ensuring effective cross-functional teamwork among project team members including both internal and external stakeholders
- Serve as escalation point for clinical project issues, within area of project responsibility, to internal and external stakeholders, as appropriate
- Establishing working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business
Senior Clinical Research Associate
Labcorp Drug Development
05.2019 - 02.2021
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits
- Activities as Lead CRA for Americas: management of CTMS issues, eTMF review, update of CTMS system (site level milestones), review of reported PDs (protocol deviations)
- Act as buddy/mentor of new hires.
- 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; Ensure audit readiness at the site level
- Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Clinical Research Associate II
Labcorp Drug Development
09.2016 - 04.2019
- Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
- Responsible for all aspects of site management as prescribed in the project plans
- Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
- Ensure the resources of the Sponsor and organization are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to travel policy
- Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
- Independently perform CRF review; query generation and resolution against established data review guidelines on organization or client data management systems as assigned by management
- Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE
Clinical Research Associate I
Docs Resourcing Excellence (Icon Plc)
06.2013 - 08.2016
- Planned and conducted site selection, site initiation, site monitoring and site close-out visits according to the international guidelines (ICH/GCP), SOPs and local requirements
- Planned, executed and supported clinical site management activities; produced visit report and follow letters
- Ensured the quality and integrity of the data collected in Amgen-sponsored clinical trials in accordance with the approved protocol, SOPs, ICH/GCP and regulatory requirements
- Supported the needs of internal and external clients or stakeholders
- Supported site team on ethical and regulatory aspects
- Trial master file setup, review and maintenance
- Study supplies management and accountability
- Dealt with sponsor-generated queries in a timely manner
- Maintained site and sponsor contact and performed archiving and in-house activities.
Clinical Research Assistant
RPS do Brazil Servicos de Pesquisa
05.2012 - 11.2012
- Performed co-monitoring visits
- Assisted CRA to achieve the timeline of data Base lock
- Assisted CRA in the site management and to perform monitoring visits reports and follow-up letters
- Organization and maintenance of study files
- Reviewed regulatory documents at site and in-house
- Performed drug accountability and drug records accountability review
- Reviewed and tracked safety reports and the correct submission to IRB.
Clinical Research Trainee
Sanofi-Aventis Farmaceutica LTDA
02.2011 - 04.2012
- Participated in site selection, site initiation, site monitoring and site close-out visits, conducted according to the international guidelines (ICH/GCP), SOPs and local requirements
- Supported the development of monitoring reports to the sponsor
- Reviewed periodically the study files in order to ensure that all required documents are available, accurate and complete
- Participated in periodic teleconferences (as listener) with the global teams in order to provide them with updated information about the status of the studies in Brazil and to align the strategy globally
- Supported the preparation and submission of regulatory and ethical dossiers and related documents to the Ministry of Health and National Institutional ethics committees in order to get the approval for the conduction of clinical trials
- Supported the preparation, collection and archiving of essential documents in accordance to GCP
- Supported the development of annual and final study reports to ANVISA.
Education
Bachelor of Science - Pharmacy And Biochemistry
Universidade De São Paulo - USP FCFRP
Ribeirão Preto, Sao Paulo, BrazilMBA - Project Management
Fundação Getúlio Vargas
São Paulo, Sao Paulo, Brazil01.2024
Skills
- Analytical and strategic skills
- Complex Problem-Solving
- Effective communication
- Cross-Functional Teamwork
Main Therapeutic Experience
- Metabolic and Cardiovascular: Dyslipidemia, Hypercholesterolemia, Type II Diabetes, Atherosclerosis, Acute Myocardial Infarction, Peripheral Artery Disease
- Oncology: Breast, Gastric, Prostate, Lung cancer
- Infectious Disease: Bacterial Disease Therapy: UTI, Vaccines for respiratory syncytial virus in infants (RSV)
- Gastroenterology: Non-Alcoholic Steatohepatitis (NASH)
Languages
Portuguese
Bilingual or Proficient (C2)
English
Advanced (C1)
Spanish
Advanced (C1)
Timeline
Manager, Clinical Operations
Fortrea
10.2022 - Current
Associate Manager, Clinical Operations
Labcorp Drug Development
10.2021 - 09.2022
Clinical Team Lead
Labcorp Drug Development
03.2021 - 09.2021
Senior Clinical Research Associate
Labcorp Drug Development
05.2019 - 02.2021
Clinical Research Associate II
Labcorp Drug Development
09.2016 - 04.2019
Clinical Research Associate I
Docs Resourcing Excellence (Icon Plc)
06.2013 - 08.2016
Clinical Research Assistant
RPS do Brazil Servicos de Pesquisa
05.2012 - 11.2012
Clinical Research Trainee
Sanofi-Aventis Farmaceutica LTDA
02.2011 - 04.2012
Bachelor of Science - Pharmacy And Biochemistry
Universidade De São Paulo - USP FCFRP
MBA - Project Management
Fundação Getúlio Vargas
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