Ajay Shinde

Experience

• 

  Tata Consultancy Services

  Jul 2018 - Jun 2019

  * Review and analysis of different types of clinical trails and related data,identify quality issue based on Data Quality Guidelines.* Extract data from protocol/Clinical Study Report as per requirements.*Make effective documentation .*Perform De-duping activity on different types of data in CTMC of HCP,HCF,etc and prepare a master data which is Golden Set of Record.

  • Regulatory Document Publishing

    Jan 2019 - Jun 2019

  • Master Data Management

    Jul 2018 - Dec 2018
• 

  IQVIA

  Jul 2019 - now

  ➤ LLRR entry, QC, data review, data cleaning, discrepancy management, eDC ➤ Involved in Start-Up, Conduct and Close out activities.➤ Identifying errors, discrepancies, true alerts and presenting data related to local lab data review and discrepancy management ➤ Lab data reconciliation and providingtrainings to the team.➤ Conducting peer review of the lab reports of the allocated projects to ensure the safety and efficacy of the drugs.➤Prepration of medical surveillance review summary of lab and ECG listing to present during Medical call at desired frequency.➤ Participate in the startup activities involving inKOM and other internal/external meetings ➤ Working hand in hand with the Therapeutic Medical Advisors and other cross functional teams for the successful deliver of the projects. ➤ Involved as Lead in the various complextherapeutic projects and supports the medical team during database lock.➤ Maintain strong internal/external customer relationships to manage and meet the contractual obligations.Therapeutic area expertise in Phase 1, 2 and 3 trials (COVID studies, Oncology,Endocrinology, Gastroenterology trials,etc) Show less Functions• Monitor, and evaluate laboratory results on a daily basis from sponsor-designated central laboratory• Evaluating and analyzing laboratory data at agreed frequency from sponsor-designated data management system/eDC platform• Conduct preliminary review of laboratory results relative to established protocol-specific reference range guidelines, using relevant clinical laboratory experience and compares current results with prior laboratory values to evaluate or note clinically significant increases/decreases and contacts the investigator site for pertinent additional clinical contact for distribution to project team• Serve as liaison between the Medical Services Department and sponsor-designated laboratory and the IQVIA Project Team• Maintain up-to-date laboratory knowledge via continuing education activities or attendance at medical seminars• Based on clinical laboratory and monitoring experience, identify potentially significant trends or shifts in laboratory results and alerts IQVIA Medical Advisors• Interact with project team to convey critical information that may impact study objectives• Work with central laboratory staff to facilitate appropriate monitoring and reporting of subject laboratory results• Assists Lead Medical Surveillance Specialist with project set-up activities• Attends project team meetings, as needed• Performs other related duties as assigned Show less

  • Lead Medical Surveillance Specialist 1

    Aug 2022 - now

  • Medical Surveillance Specialist 1

    Dec 2021 - Sept 2022

  • Associate Medical Saftey Surveillance

    Jul 2019 - Dec 2021