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AmgenLocal Trial Manager Brazil - Oncology - Global Development
Feb. 2023 - Oct. 2024São Paulo, BrasilIn this position, I work as clinical trial Lead for the Brazilian leg of Amgen's clinical trial, at the moment I am responsible for managing a fast-lane clinical trial on cancer patients. My main responsibilities are liaising with global and local teams, to oversee interdisciplinary clinical research studies and ensure compliance with GCP, relevant SOPs, and regulatory requirements. I liaise daily with the company's global team CRO FSP and sites to ensure timely study launch, conduct, and closeout according to the Customer’s and the Company’s contractual agreement. It is my responsibility to lead the project team to ensure quality, timelines, and budget management. I am accountable for dealing with reimbursement requests and keeping track of all decisions made in the study at the country level. I
coordinate activities and deliverables of all study conduct partners and proactively identify and manage issues and I ensure studies are conducted in compliance with GCP, relevant SOP, and regulatory requirements.
Please see below the main skills I am developing and using working in this position:
- GCP and ethical compliance
- Quality oversight
- Site startup, selection and close-out
- Partnership with CRO
- Fast-lane clinical trial
- prioritization
- project management
- planning and oversight
- leadership
- data management and cleaning
ENDPOINT HEALTHClinical Operations Research Consultant - Brazil
Nov. 2021 - Jan. 2023São Paulo, BrazilResponsible to oversee clinical operations study attributes to clinical research studies in Brazil. In this position, I often liaise with the site coordinator, principal investigators, and third-party vendors. I am responsible to organize research sample logistics, importation and exportation of samples, and project finance management. I work often coordinating all study activities in compliance with GCP documentation and ethical regulations. I am responsible to manage study timelines, overseeing CRAs working and monitoring letters, reporting project status updates and reporting financial expenditure of project activities.
ENDPOINT HEALTHClinical Research Consultant
Oct. 2021 - Jan. 2023São Paulo, BrazilAt this position I am responsible to liaise with vendor, research centres and investigators to organize study material logistics, study procedures and clinical operations of clinical research sponsored by EP health that is being carried out in Brazil. - GCP
CLINERGY Health ResearchLead Clinical Research Associate
Jul. 2021 - Nov. 2021São Paulo, São Paulo, BrazilAs a Lead CRA, in this role I was expected to act as a leader and provide training and information for less experienced CRAs, to carry out all the basic monitoring activities, such as monitoring of research sites, SIVs, COV, eCRF training, TMF maintenance, ethics submission, site training. I also liaised with researchers, site coordinators, and sponsors, and I am set to be responsible to ensure patients’ rights are being met and that sites and researchers are in compliance with IRB/EC, HA, GDPR, and GCP regulations. I was also responsible to collect documents and preparing and maintaining study TMF and ISF. I also review SAE data and eCRF. Responsible to lead risk assessment of research projects and preparing monitoring plans based on risk monitoring. I was the lead CRA of two Covid-19 clinical trials, that are looking for treatment strategies for moderate to severe cases of Covid.
Hospital Sírio-LibanêsResearch Project Specialist
Jun. 2019 - Jun. 2021São Paulo, São Paulo, BrazilThis position was held at the Social Responsibility department at Sírio-Libanês Hospital. - I helped to build the research team at PROADI - SUS from two (research manager and project specialist up to 8 professionals, including 4 CRAs;
- I have liaised with 8 principal investigators and over 20 MDs;
- Coordinated 6 research studies: 5 multicentric clinical trials (cancer, sepsis, covid-19, brain injury, and tracheobronchitis) and 1 epidemiologic study (profile of ICU patients in Brazil);
- Over 45 thousand patients recruited for the epidemiologic study since December 2019;
- Almost 300 patients recruited to Covid-19 trial published at JAMA and at WHO Covid-19 guidelines;
- I have carried out research initiation visits in over 60 research sites spread in Brazil for all the studies;
- I have trained over 245 health professionals on the Codex Trial (covid-19 study) only: trained in the research protocol, data collection using RedCap, and good clinical practice;
- Central monitoring do data quality and CRFs
- I have coordinated the logistics of sending over 4000 doses of dexamethasone to study sites in Brazil for Codex trial; - I have liaised with ANVISA and health secretaries from the Brazilian Ministry of Health;
- Developed and validated research documents, investigator brochure, consent forms, and study binder;
- Responsible to ensure GDPR, ethics, and health regulations compliance of all research projects;
- Act as a product owner of research for about 4 months;
-I often dealt with research budget, risk assessment and management, team training and audit process, annual reports and diligences;
Hard and soft skills: project management and agile methodology; good clinical practice, clinical trials, phase 3 study, site initiation, and monitoring, GDPR, ethics, data monitoring and analysis; leadership, organization, time-management, communication, proactivity, leadership, research governance.
Cambridge University Hospitals NHS Foundation TrustResearch Governance Co-ordinator
Aug. 2018 - Feb. 2019Cambridge, United KingdomThis position was held at the Research and Development Department at Cambridge University Hospitals and my main responsibility involved managing and coordinating research applications to the UK regulatory bodies (Research Ethics Committee, Health Research Authority, Medicine and Healthcare Products Regulatory Agency) and to the NHS trust, ensuring the best good clinical practice.
- I have coordinated 30 clinical research projects (clinical trials, cohort studies, case-studies and epidemiologic studies);
- Out of the 30 clinical research projects, 10 were commercial clinical trials on phase 3;
- I have liaised with principal investigators, medical residents, regulatory bodies, legal department, hospitals areas involved in determined research project, CRAs, research teams, hospital staff and practitioners;
- Worked as gate-keeper between sponsor, CROs and principal investigators;
- Provided ICH GCP R2 training to hospital investigators and staff;
- Evaluated investigator brochure, study binders and research documents;
- Coordinated research submission of protocol, ethical submission and amendments;
- Coordinated research documents compliance with Ethics regulations, HRA regulations and GDPR;
- Coordinated research budget for non-commercial studies and approved research budget for commercial studies;
- Reviewed research legal contracts.
Hard and Soft Skills: Research governance, GCP, UK Health and Research regulations, IRAS form application, Reda® and Edge® systems; Analyse contracts and confidentiality agreements; Analysing and negotiate costing for commercial and non-commercial research; teamwork, time management, project coordination, collaboration, problem solving, pro-activity, public health knowledge.
Cambridgeshire and Peterborough CCGResearch Officer - Health Evidence, Knowledge and Intelligence
Jul. 2017 - Jul. 2018Cambridge, United KingdomThis position was in the department of Health Evidence, Knowledge and Intelligence and I work in collaboration with the Research and Development Team, providing scientific evidence to enhance policies that are currently being considered by the CCG. - I’ve liaised with clinical commissioners, general practitioners and health regulatory bodies
- I’ve provided scientific evidence to 10 business cases in primary care
- I wrote the first draft of a primary care prevention health strategy, including sROI and purpose
Hard and Soft Skills: Research, literature review, health economics (basic level), data analysis, data reporting, infographics (basic level), teamwork, time management, project coordination, collaboration, problem solving, pro-activity, public health knowledge. Use of Office 365® and Canvas® (user level).
Anglia Ruskin UniversitySports Activator
Sep. 2014 - Nov. 2015Cambridge, Reino UnidoAs a sports activator, I was completed insert in the Universiy community as I
was responsible for engaging students and staff in participating in sports activities that were pre-organized by the University. I was also responsible for teaching my own class (running group) and to also receive and help professionals in other exercises classes.
CNA Idiomas | OficialLanguage Teacher
Jan. 2013 - Sep. 2013São Paulo e Região, BrasilAt this position, I was responsible for preparing and teaching language
classes, following the school's specific materials, resources, and methodology for children, teenagers and
adults. I was also responsible for creating and organizing cultural activities that would help engage
students in their learning. I had to evaluate students level's and skills on the specific language they were being taught and to assist the school coordinator with administration issues, such as other's teachers' timetables, student's grades and levels, parents meeting and organizing courses materials.
FisioPrevPhysical Therapist
Aug. 2011 - Oct. 2011Osasco, SP- Clinical Physiotherapist assistance (evaluation, treatment and orientation) on the follow areas: orthopaedics and neurological rehabilitation (adults and kids).
FiocruzResearch Assistant
Mar. 2011 - Aug. 2011São PauloResearch Training for the trial: “Birth in Brazil” (research about labour and birth in the country) (2011) - FioCruz.
Researcher collecting data with women post-labour in hospitals and maternities of west Sao Paulo, Brazil.
UNIFESPPhysical Therapist
Mar. 2011 - Jun. 2011São Paulo- Physiotherapist assistance to pregnant women (healthy pregnancy, risk pregnancy and malformation): control of lumbar/leg pain, preparation to the labour, evaluation of pelvic muscles, uterine height, breast and general conditional and exercise and daily activity orientation;
- Assistance during labour, birth and postpartum period.
- Write reports about patient evolution and conduce therapy and orientation groups.
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