Florencia Falguera

Experience

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  Lacyb MONTE (Clinical and Bacteriological Laboratory)

  Sept 2012 - Feb 2013

  Clinical Laboratory Technician

  My duties included: performing analytical testing in accordance with policies, quality control guidelines, and compliance standards and preliminary processing of all specimens entering the department. Maintaining and monitoring automatic analyzers including the running and interpreting of controls.

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  CENATOXA (Analytical Toxicological Counselling Centre)

  Feb 2013 - Jan 2016

  Specialization: Clinical & Analytical Toxicology

  • Received and collected blood samples from patients, managed client and doctor communication, and performed comprehensive biological analyses (urine, blood, hair, nails) and non-biological samples (vegetables, soil, powder, water) following SOP. • Conducted analyses for various analytes including drugs, metals, pesticides, diuretics, solvents, and others, ensuring meticulous attention to detail and accuracy throughout the process. • Analyzed data and prepared final reports, showcasing a commitment to superior quality, safety, and timely results. • Took charge of the maintenance and calibration of analytical instruments such as GC, GC-MS, UPLC, and AA, contributing to reliable and precise analytical outcomes. • Prepared reagents and standards (commercial and in-house), trained new staff, created processes, established methods, and designed experiments aligned with regulatory requirements and company priorities. • Developed and validated analytical methods, contributing to the advancement of laboratory capabilities. • Managed the ordering and review of laboratory equipment, consumables, and inventories, ensuring a well-equipped and efficient laboratory. • Oversaw safety audits and recommended corrective actions, prioritizing a safe and compliant working environment. Show less

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  Subject: Toxicology

  May 2013 - Jan 2016

  Assistant professor

  • Delivered engaging lectures and facilitated discussions in Toxicology. • Developed and updated course curricula to align with the latest educational standards and industry trends. • Participated in academic committees and contributed to departmental initiatives. • Collaborated with colleagues on research projects and interdisciplinary initiatives. • Provided constructive feedback and assessed student performance through examinations, assignments, and projects. • Engaged in professional development activities to enhance teaching and research skills. Maintained office hours to support student inquiries and academic discussions. • Supervised and evaluated students' laboratory work in Toxicology, providing guidance on experimental procedures and safety protocols specific to the discipline. • Prepared laboratory materials and reagents for practical class work in Toxicology, facilitating hands-on learning experiences tailored to the subject area Show less

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  The International Association of Forensic Toxicologists – TIAFT

  Nov 2015 - Jan 2021

  Chair of the Young TIAFT Latin America Committee. Volunteer job.

  TIAFT is an International organization that every year organize one international and one regional (Latin America) meeting in different countries of the world. Young TIAFT is a group inside these big family of young scientists (younger than 40 years old).- Organizing the Annual Young Scientists meeting in different countries of Latin America.- Media and communication managing.- Reading and evaluating the abstract that the young scientist send to each meeting.- Keeping monthly informed the board TIAFT members about Young TIAFT activities.- Writing the annual reports for the TIAFT Bulletin. Show less

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  SAFE Analytical Laboratories

  Jan 2017 - Jul 2017

  Analytical Chemist

  • Performed analysis of biological (urine and hair) and non-biological (water and soils) samples from inception to completion, following standard operating procedures and meticulously searching for analytes. • Conducted specialized testing for Kryptopyrrole in urine using the 'novel' UKp test, an accredited method used by medical practitioners. • Determined basic parameters, cations, anions, trace elements, and toxic elements in drinking water, wastewater, and surface water using Ion chromatography-conductivity detector. • Maintained laboratory instruments, ensuring their proper functionality and accuracy. Conducted quality control tests to validate the accuracy and precision of laboratory results. • Organized lab test solutions, compounds, and reagents, streamlining laboratory workflows. Routinely calibrated scales and pipettes to minimize errors and ensure measurement accuracy. • Adhered to NATA requirements, upholding the laboratory's commitment to quality and accreditation standards. Show less

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  TetraQ

  Aug 2017 - Aug 2021

  • Managed multiple clinical trial studies, ensuring adherence to timelines and compliance with internal and Customer quality standards, SOPs, GCPs, regulatory requirements, and ICH guidelines, meeting federal and local regulations. • Conducted project management activities for the small molecules (LC-MS/MS) department, strategically allocating resources across multiple projects to minimize delays and execute high quality, cost-efficient clinical studies. • Oversaw all phases of PK bioanalytical studies, including study planning, technical monitoring, resource management, investigations, troubleshooting, data analysis, interpretation, quality control, data transfer, report preparation, archiving, and client liaison. • Ensured scientific integrity and regulatory compliance of study data through meticulous source document review. • Obtained and maintained essential documentation in compliance with ICH-FDA-EMA and GLP. Effectively communicated with clients, providing regular updates on the progress of their studies and addressing any concerns. • Troubleshot scientific issues by collaborating with relevant groups within the organization. • Wrote, reviewed, and approved SOPs to maintain standardized processes within the department. • Developed and validated LC-MS/MS, HPLC, and UPLC methods for small molecules projects in accordance with EMA and FDA bioanalysis guidelines. Promoted and maintained a greener and environmentally friendly facility, aligning with sustainable practices. Show less • Developed HPLC and UPLC MS/MS methods for small molecules in diverse biological matrices, supporting clinical trial research. • Conducted hands-on experience in bioanalytical method validation and sample analysis using HPLC and UPLC MS/MS, adhering to EMA and FDA bioanalytical method validation guidelines for clinical trials. • Performed sample analysis utilizing immunoassay methods with Electrochemiluminescence detection for large molecules. Executed hands-on experience in the extraction of drugs and metabolites from biological matrices using various techniques, including protein precipitation, liquid-liquid extraction, and Solid Phase Extraction. • Calibrated instruments according to TetraQ deadlines, covering mass detectors, balances, pipettors, steppers, pH meters, centrifuges, thermometers, timers, and volumetric glass, ensuring precision in clinical trial data collection. • Operated various analytical instruments, including SCIEX API3200, API4000, QTRAP4000, QTRAP5500, Shimadzu HPLC, Shimadzu UPLC, and Meso Scale QuickPlex SQ120, contributing to clinical trial analysis. • Demonstrated efficiency in handling diverse laboratory software, such as AB SCIEX Analyst® Software and Meso Scale Discovery Workbench, integral for clinical trial data processing and interpretation. Show less

  • Study Director / Principal Investigator

    Dec 2018 - Aug 2021

  • Scientist

    Aug 2017 - Nov 2018
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  Novotech

  Aug 2021 - Sept 2024

  • Develop, review, and approve a comprehensive array of data management study-related documents, including eCRF/Database specifications, Edit Check Plan specifications, Data Management Plan, UAT Plan, Data Review Plan, CRF Completion guidelines, Lab Data Transfer Agreements, SAE data transfer agreements, Validation Plans, and Project Plans/Timelines, among others. • Execute and oversee all data cleaning activities, encompassing query management, continuous data review, vendor data reconciliation, issue identification, data trend analysis, and coordination of cross-functional data review/reconciliation among supporting DMs, CDP, coder, Medical Monitors, and CRAs. • Manage all aspects of database build and updates activities, including database validation, User Acceptance Testing, and review and execution of database updates. Represent Data Management in internal study teams, Sponsor global, and DM calls meetings. • Actively review data quality by providing data management metrics, reviewing query reports, completing Source Data Verification and data cleaning activities. • Utilize metrics to identify process improvements and potential risks. Collaborate with external vendors (safety laboratories, pharmacovigilance, IRT vendors, etc.) to formulate data transfer documents and conduct regular data reconciliation. • Programmed vendor reconciliation listings in Power Bi. Monitor timelines and efficiently manage resources to meet deadlines without compromising data quality. Participate in monthly DM billing activities, collaborating with Project Managers. • Train and supervise direct team members in daily activities. Demonstrate a solid understanding of regulatory guidelines, including FDA, EMA, ICH, and GCP. • Coordinate internal resources and third-party vendors to develop change management plans for new and existing projects. • Selected participant in Clinical Data Manager competency framework activities, contributing expertise to shape industry standards. Show less • Independently reviews clinical study data with EDC systems, generates queries as needed, and collaborates with site data entry staff and Clinical Research Associates (CRAs) to ensure accurate reporting of collected data. • Draft comprehensive data-related manuals and plans, including the Data Management Plan, Data Review and Quality Specifications, eCRF Completion Guidelines, and Data Validation Specification.• Submits near-final documents for limited review and approval by the Data Manager. • Conduct database User Acceptance Testing, encompassing high-level script writing and execution.• Maintains and tracks monthly clinical research project data metrics, providing valuable insights to assist the Clinical Data Manager in analyzing, identifying, and reporting data trends. • Assists the Data Manager in data reconciliation, including SAE and external lab data reconciliation. Manages database user administration tasks, including granting, modifying, and revoking access rights. • Adheres to established timelines for assigned projects, ensuring timely completion of tasks.• Collaborates extensively with project leaders, clinical team members, and Sponsors to address clinical data needs. • Participates in training clinical team members to enhance overall team proficiency. • Performs additional duties as assigned, contributing to the overall efficiency of the Clinical Data Management function. • Acted as a backup Clinical Data Manager, demonstrating proficiency in assuming managerial responsibilities and ensuring the seamless continuation of data management activities during the absence of the primary manager. Show less

  • Clinical Data Manager

    Oct 2022 - Sept 2024

  • Senior Clinical Data Associate

    Aug 2021 - Oct 2022
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  EDETEK Inc.

  Sept 2024 - now

  Senior Clinical Data Manager

  Working under contract with Awwcor, Inc.