• Work with the Medical and Safety Data Review teams to ensure deliverables associated with Medical Data Review (e.g., summary of clinical trial data) are met, including patient profiles, safety listings & other data listings; • Participate in the preparation of medical monitoring plans in collaboration with Drug Safety and Medical Data Review teams; • Follow up protocol questions and respond to CRAs/Sites under direction and supervision of the global study Therapeutic Medical… Show more • Work with the Medical and Safety Data Review teams to ensure deliverables associated with Medical Data Review (e.g., summary of clinical trial data) are met, including patient profiles, safety listings & other data listings; • Participate in the preparation of medical monitoring plans in collaboration with Drug Safety and Medical Data Review teams; • Follow up protocol questions and respond to CRAs/Sites under direction and supervision of the global study Therapeutic Medical Advisor; • Collaborate with Project Leads and Contract Analysts to review and finalize the contract/budget and future COs; • Prepare for and where required attend Safety Review Meetings with Sponsors under the supervision of the global Medical Advisor and the Medical Safety physician, covering areas such as: Safety Listings and Protocol Deviations Log review; • Coordinate activities and ‘flow of information’ with Medical Safety Advisor, Medical Data Reviewer and Medical Surveillance Specialist during study start up and throughout the project lifecycle, such as: participate in the preparation of information and summary slides for client meetings and manage action items from Medical Delivery Services Kick-off Meetings (KOMs); • Conduct electronic Trial Master File (eTMF) maintenance in relation to Medical and Scientific Services activities; • Prepare presentation materials under the supervision and review of the global TMA, such as: Investigator meetings, Protocol training, CRA training, Program kick-off meetings. Show less

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• Responsible for managing Phase I-III clinical studies at country level, ensuring study is being conducted appropriately and in accordance with ICH GCP Guidelines, Local Regulations and Company's SOPs; managing clinical risks throughout the project’s lifecycle, to ensure clinical quality delivery within the planned timelines;• Reviewing Site Monitoring Reports as defined in Study's Monitoring Plan in order to ensure the trial is being appropriately conducted at site, supporting Study… Show more • Responsible for managing Phase I-III clinical studies at country level, ensuring study is being conducted appropriately and in accordance with ICH GCP Guidelines, Local Regulations and Company's SOPs; managing clinical risks throughout the project’s lifecycle, to ensure clinical quality delivery within the planned timelines;• Reviewing Site Monitoring Reports as defined in Study's Monitoring Plan in order to ensure the trial is being appropriately conducted at site, supporting Study Oversight, risk identification and mitigation at site level;• Conducting Country and Site Feasibility for new clinical studies, ensuring Brazil's representation in high-priority trials;• Discussing and following-up on recruitment status at the country level with investigators and sites, mapping the recruitment challenges and barriers in order to achieve the country commitment, contributing to meeting the required number of enrolled patients for the study;• Ensuring investigational site preparation and readiness for the execution of the protocol leading to site activation;• Responsible for evaluation and processing of payments to investigational sites as per negotiated study budget;• Managing timely and accurate documentation of study progress at the country level;• Managing the Local Study Team to support milestone achievement;• Establishing and maintaining relationship with sites, institutions and clinical investigators in order to consolidate the company as sponsor of choice;• Attending site visits as applicable in support of project delivery;• Accountable for study closure at site and country-levels upon completion of study activities, contributing to the closure of the study globally, costs saving, resource sparing and freeing of human capability for allocation in other higher-priority activities;• Reviewing the specialized literature and preparing scientific content to support Clinical Scientists and Medical Monitors and Investigator Meetings. Show less

As a Clinical Research Analyst at Techtrials on behalf of Roche I was responsible for:• Managing Informed Consent Forms (ICFs) and ensure compliance with GCP and local regulations;• Updating recruitment platforms according to the recruitment plan, ensuring accurate and up-to-date information was available for physicians and patients leading to target enrollment achieving at the site and country levels;• Performing risk assessment and quality check activities monthly, resulting… Show more As a Clinical Research Analyst at Techtrials on behalf of Roche I was responsible for:• Managing Informed Consent Forms (ICFs) and ensure compliance with GCP and local regulations;• Updating recruitment platforms according to the recruitment plan, ensuring accurate and up-to-date information was available for physicians and patients leading to target enrollment achieving at the site and country levels;• Performing risk assessment and quality check activities monthly, resulting in a risk visualization dashboard to support Study Managers oversight and audit/inspection readiness;• Onboarding new hires, supporting their integration into the company's culture and processes;• Updating training curriculum tools, ensuring team compliance with training requirements;• Maintaining and updating clinical trial systems, ensuring accurate and up-to-date information. Show less

• Responsible for performing risk assessment and quality check activities monthly, resulting in a risk visualization dashboard to support study managers activities and oversight and audit/inspection readiness, embedding compliance, quality and process improvement in the Clinical Operations Department in Brazil;• Provided support with ethical and regulatory document preparation;• Maintained clinical trial systems and supported the site start-up processes by obtaining the required… Show more • Responsible for performing risk assessment and quality check activities monthly, resulting in a risk visualization dashboard to support study managers activities and oversight and audit/inspection readiness, embedding compliance, quality and process improvement in the Clinical Operations Department in Brazil;• Provided support with ethical and regulatory document preparation;• Maintained clinical trial systems and supported the site start-up processes by obtaining the required documents per GCP, company's SOPs and local regulations. Show less

• Proposed and designed the Project "Development of Y-family TLS DNA Polymerase inhibitors for synthetic lethality in tumor cells", in a collaboration between the DNA Repair Laboratory and the Structural Genomics Consortium, with the support from the Sao Paulo Research Foundation;• Designed and conducted wet lab experiments, analysing and interpreting the results using apropriate statistics and biostatistics softwares in order to answer the scientific questions of the project;• Prepared… Show more • Proposed and designed the Project "Development of Y-family TLS DNA Polymerase inhibitors for synthetic lethality in tumor cells", in a collaboration between the DNA Repair Laboratory and the Structural Genomics Consortium, with the support from the Sao Paulo Research Foundation;• Designed and conducted wet lab experiments, analysing and interpreting the results using apropriate statistics and biostatistics softwares in order to answer the scientific questions of the project;• Prepared scientific reports and manuscripts based on the obtained experiment results and literature review;• Created scientific materials for conferences, congresses and scientific meetings presentations. Show less

Project: Effects of ATR inhibition in the sensitivity of HPV +/- cervical tumor cells to cisplatin

I was awarded the CNPq Pre-College Research Fellowship to develop the Project: Effects of transformation of XP cells by HPV E6 and E7 genes on UV light responses