Tomas Agustin Juarez Melgarejo

Experience

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  Grupo OSDE

  Oct 2014 - Apr 2018

  Call Center and Back Office Consultant

  My main task was to receive incoming calls and provide advice to our clients about their coverage,account, and contract, including the requirements and documentation needed to audit different medical studies, surgeries and the provision of medical supplies such as medications, surgical prostheses or orthopedic supplies.In December 2015 I started working in the Back Office one week per month. I was in charge of receiving documentation, validating that it was complete and correct, referring it to the corresponding areas to be evaluated, and finally giving feedback to the client about the result of the process.In May 2017 I started working as Tutor one week per month. I provided support to novice consultants and worked to solve complex/urgent queries and claims of the clients. I assisted claims when clients wanted to talk to a supervisor and I evaluated how to solve our client´s problem. Show less

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  PRA Health Sciences

  May 2018 - Jul 2021

  Providing services to Merck Sharp & DohmeAs a Lead CDM I am leading all data management activities pertaining to clinical trials from Phase I, from Start Up until Data Base Lock. In this role I am accountable for the quality and timely execution and delivery of Global Data Operations deliverables at the trial level. I am responsible to develop, validate, review, approve and maintain data management tool specifications (eCRFs, Time&Events Schedules, Entry Guidelines, Data Review Plans and Data Management Plans) and coordinate User Acceptance Testing of new data management tools.I perform query management and Data Base Lock preparation and I am the principal point of contact for our Sites, Clinical Team, Statisticians and External Vendors for any issue related to DM. Show less Providing services to Merck Sharp & DohmeAs an EDEV SCDM I am leading all data management activities pertaining to clinical trials from Phase I, from the moment the First Patient is enrolled until the Data Base Lock is reached. In this role I am accountable for the quality and timely execution and delivery of Global Data Operations deliverables at the trial level. I am responsible to validate, review, approve and maintain data management tool specifications (eCRFs, Time&Events Schedules, Entry Guidelines, Data Review Plans and Data Management Plans) and coordinate User Acceptance Testing of new data management tools.I perform query management and Data Base Lock preparation and I am the principal point of contact for our Sites, Clinical Team, Statisticians and External Vendors for any issue related to DM. I am currently working on Infectious Disease Trials and participating on the Data Review SME Team. Show less Providing services to Merck Sharp & Dohme.As a SCDM I continued executing end to end data management activities pertaining to clinical trials from Phases II to IV. In this role I continued performing Data Review activities but I also worked in the development of new validation tools, in the maintenance of the Data Base Specifications and was in charge of leading several discussions with the Clinical Team and the Statisticians. I assisted my Lead CDM coordinating the Data Management team (which was over 30 members), performing quality assessments, sharing metrics, training new CDMs and negotiating timelines with our Clinical Operation's colleagues. As an SCDM I worked as an LNMT SME (Oracle's tool used to register Labs Normal Ranges) and in the Metrics team.I continued working in Cardiovascular trials but also in Respiratory and Endocrinology trials. Show less Providing services to Merck Sharp & Dohme.As a CDM I was responsible for executing end to end data management activities pertaining to clinical trials from Phases II to IV. I was mainly oriented to perform Data Review and solve discrepancies working with the sites and CRAs. During my Data Review activities I needed to evaluate that our Validation Tools and the Data Base were working as expected and escalate any potential issue to the Senior and Lead CDM.I worked different TAs such as Vaccines and Cardiovascular Show less

  • Lead Clinical Data Manager (LCDM)

    Dec 2020 - Jul 2021

  • Early Development Senior Data Manager (EDEV SCDM)

    Apr 2020 - Nov 2020

  • Senior Clinical Data Manager (SCDM)

    Mar 2019 - Apr 2020

  • Clinical Data Manager (CDM)

    May 2018 - Feb 2019
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  MSD

  Jul 2021 - now

  Responsible and accountable for ensuring quality and consistent end to end data management deliverables. Accountable for providing comprehensive technical guidance and design specific recommendations to the Lead Clinical Data Managers. Interact with staff across multiple departments and serve in the role of mentoring, guiding, and providing project leadership.

  • Principal Clinical Data Manager

    Jan 2023 - now

  • EDEV Lead Clinical Data Manager

    Jul 2021 - Dec 2022