Allyson Gianini

Experience

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  All Pharma Jr. - Consultoria Farmacêutica

  Jun 2006 - Jul 2007

  Member of Quality Department

  - Development of trainings to capacitate and motivate the employees of the company, around the quality programs already in use, like the 5S.- Development of politics to implant new quality programs, like Total Quality and Six Sigma. -Development of trainings to improve the quality of the company´s services, focusing on the customer´s service. - Aplication of trainings to the new employees of the company, around the role and importance of each one in the maintenance of the company´s quality programs. Show less

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  Laboratórios Pfizer Ltda.

  Aug 2007 - Nov 2007

  Junior Analyst of Documentation (temporary)

  - Follow-up and development of processes related to the production of sterile liquids. - Involvement in team working on the improvement of information´s flown and formalization. - Development, review and formalization of procedures related to the production of sterile liquids. - Development and application of trainings related to the production´s processes, to the co-workers.

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  Johnson & Johnson Industrial Ltda.

  Nov 2007 - Dec 2008

  Intern

  Project Management Intern (ROC and Neutrogena brands) - Project management of new products development for the national and international market, from the product´s early concept idea, until your introduction in the market and the further export mainly to Latin America.- Development and approval of MS Project timelines, with each team involved on the projects. - Development of risk assessment trying to reduce possible risks related to the success of the projects, to guide the decisions and establish mitigation plans.- Development of cost studies to analyze the project´s feasibility - Management of the project team´s meetings, to establish targets and deadlines, trying to focus on priorities and results.- Follow-up of the related areas ‘activities, trying to motivate the co-workers and to discover opportunities of process improvement.- Weekly project´s reports development to the main Office abroad. Condoms Plant Intern (Jontex)- Development of a preservative system to the condoms ´impregnation solution, to reduce the microbiological count in order to adequate the same to the new limits established by ANVISA in the RDC No 62 - Determination of the pilot plant´s parameters, to possible further studies involving improvements of the formula. - Studies with micronized raw-materials in order to reduce the quantity of the same in the formula, although, without reducing the effectiveness of the reaction, or the product´s quality.- Involvement in meetings with the marketing area to adequate the new products ‘development to the plant reality. Show less

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  Eli Lilly and Company

  Mar 2010 - Aug 2010

  Validation Assistant (temporary)

  - Development and execution of equipment qualifying protocols (IQ, OQ, PQ) and validations of process and cleaning, in the contract manufacturing companies and Elanco’s plant;- Manufacturing process evaluation to identify opportunities of improvement and cost reduction related to production and packaging processes;- Investigation of deviations related to production, packaging and distribution;- Data collection and development of annual products review reports;- Follow-up of qualifications and tests performed by the contract manufacturers, in order to certify the application of the requirements and to fulfill the deadlines;- Development and review of PFDs,VMPs, change controls and other reports related to validation/qualification; - Support to the achievement and follow-up of tests and sampling involved in the qualification and validation processes, as well as, in the development of the reports originated by them. Show less

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  Genzyme

  Aug 2010 - Nov 2012

  - CRA in charge of 05 sites, four in São Paulo and one in Recife, working on protocols of Multiple Sclerosis (MS) treatment with a monoclonal antibody. As a CRA I performed site initiation, monitoring and close-out visits. - Participation on local and international meetings.- Mapping of Clinical Research Processes, creating workflows, charts and writing local SOPs and Work Instructions for all the clinical processes, in order to better understand the Genzyme’s complexity and identify opportunities for improvements, mainly on time and costs. - Coordination of a team of 3 CTAs for the LatAm, in order to improve team communication, help them with the establishment of priorities, with time management, create regional standards and tools for the same processes through the countries (ARG, BRA, MEX).- Temporary coordination of a team of 05 CRAs for the LatAm, helping them with their doubts/ issues, improving communication abroad with the central team, reinforcing projects deadlines and escalating their issues to the Clinical Project Manager.- Performed co-monitoring visits on all sites of LatAm participating on MS studies (Argentina, Brazil and México) as part of quality initiative of Inspection Readiness, in order to better understand each site complexity and status, identify common issues, establish action plans for them and create lessons learned to be applied on future studies. At the same time, the sites were prepared to better receive future inspections by regulatory agencies.- Currently acting as a backup CRA for the extension study on MS, where the patients from previous studies continue to be followed for safety purposes. Show less - Study the documentation related to the clinical studies including (but not limited to) protocol, informed consent, study operational manual (SOM), monitor’s manual (MM) and study logistics as necessary to perform primary activities and/or delegated tasks;- Coordinate all steps of clinical study documents’ translation process and assure translation’s accuracy upon review;- Support CRA/ local regulatory affairs on requesting essential site documents and on the preparation of sites’ documents for regulatory & ethical submissions;- Support CRA on preparation of training to sites about their duties and responsibilities in the conduction of clinical studies;- Develop and maintain electronic tools and flowcharts to facilitate site’s and CRA’s work;- Assure proper implementation, maintenance and updating of study files, including but not limited to local/central electronic repository systems and hard files;- Assure that CIOMS/Medwatch reports are distributed and received by the sites in a timely manner, according to Genzyme SOP and ICH/GCP and are submitted to local Ethics Committee accordingly;- Support CRA on requesting information for the setup of study agreements with all applicable parties involved before initiating the study and to coordinate full agreements execution;- Support CRA on review and control of site payments throughout the study;- Participate in study activities such as meetings, conference call, site visits, etc, whenever requested;- Provide support to senior management, either local, regional and/or from Genzyme Corporation, whenever requested;- Coordinate the organization and implementation of investigators and/or study coordinator meetings, whenever applicable. Show less

  • Clinical Research Associate I

    Jun 2011 - Nov 2012

  • Clinical Trial Assistant

    Aug 2010 - May 2011
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  PRA Health Sciences

  Dec 2012 - Oct 2019

  • Assisted site and participated on an FDA inspection (with zero findings),• Acted for 13 months as local Data Champion in a big cardiovascular trial with 39 active sites, providing support to 14 CRAs, 3 managers and upper management, developing reports on sites performances on data entry, queries resolution, documents for adjudication, identifying queries trends per country and site, keeping track of ongoing adverse events, developing a rationale to analyze sites and identify the ones requiring more attention, in order to successfully deliver two interim analysis and final DBL on-time for deadlines proposed and according to global team’s expectations,• Assisted CRA II with preparation for a sponsor audit (with no major findings),• Assisted sites with alternative recruitment strategies to deliver country initial target proposed despite of a six months cut on global deadline,• Acting as local Data Champion for two different studies with 5 sites each, ensuring interim analysis/ data cleaning for both are being delivered on-time for deadlines;• Working remotely with sites to investigate and mitigate signals/ alerts generated by Central Monitoring Platform,• Supervising/ Mentoring other CRAs and serving as a resource for new employees, ensuring they fulfill their responsibilities in accordance with sponsor’s policies and standard procedures,• Working independently with minimal oversight and providing leadership skills to assigned projects,• Serving as subject expert for CTMS and EDC on monitoring related activities,• Performing initiation and monitoring visits on naïve and challenging investigators/ sites,• Participating in sponsor’s initiatives to improve overall studies recruitments and new sites’ prospections, as well as, challenge processes and ensure client’s expectations were met.• Supporting manager with activities and acting as backup in case of absence. Show less • Worked with multiple sites and performed co-monitoring visits, • Assisted sites in two Sponsor audits (with no critical findings) and ensured corrective actions proposed were implemented,• Performed new hire training with new study members providing information on background, decisions and changes made, systems and main points of attention of the project,• Acted as focal point between 14 CRAs and 3 managers on a big cardiovascular trial, for 11 months providing guidance on study doubts, alignment between the team, as well as, in house support to daily activities,• Developed new tools/ trackers to assist managers with study planning and execution. Show less • Ensured sponsor / investigator obligations were compliant with local requirements and ICH-GCP,• Conducted site management activities including site qualification visits, feasibility, initiation visits, training, monitoring visits and close-out visits, • Ensured Sponsor and Investigator’s files were complete and ready for audits/ inspections,• Ensured proper storage, dispensation and accountability of clinical supplies and study drug, • Ensured prompt reporting of adverse events, including Serious Adverse Events (SAE),• Escalated site issues, concerns, and progress to upper management,• Performed remote monitoring activities,• Controlled status of financial reimbursement to sites. Show less

  • Clinical Research Associate III

    Sept 2015 - Oct 2019

  • Clinical Research Associate II

    Sept 2013 - Aug 2015

  • Clinical Research Associate I

    Dec 2012 - Aug 2013
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  Sanofi

  Oct 2019 - Oct 2020

  Clinical Project Lead

  Currently responsible for 3 multiple myeloma studies (phases 2 and 3), as well as, one COVID-19 phase 1 study.

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  PRA Health Sciences

  Oct 2020 - Jan 2022

  Clinical Team Manager
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  ICON Strategic Solutions

  Jan 2022 - now

  • Project Manager

    Nov 2023 - now

  • Manager of Clinical Operations

    Jan 2022 - Nov 2023