Sriharshitha Karanam

Experience

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  BiOZEEN

  Jan 2015 - Mar 2015

  Intern

  Project Name : ‘Studies on growth of BHK-21 adherent cell line and scale up using microcarriers’. Description: Baby Hamster Kidney (BHK-21) Fibroblast cell line is one of the most commonly used cell lines for vaccine production, which are adherent and grow in monolayers. BHK 21 cells were grown with the help of monolayer Microcarrier technology eventually optimizing the growth parameters and scaling it up to industrial scale from the spinner flak to 40 L bioreactor through 5 L bioreactor. The culture parameters for the growth of the cells at every stages of the scale up were optimized. The scale up was efficient as such 6.4x10^10cells/batch was the yield, which can be used for vaccine production. Roles and Responsibilities: • Worked Sterile techniques • Worked on Bio Burden Analysis and bioreactor maintenance.• Gained practical knowledge on laboratory bio safety level, reviving of cryopreserved cells, Giemsa staining, cells harvesting, cryopreservation, karyotyping and animal cell culturing, working with bioreactor (5L, 40L) for scale up from spinner flask. Show less

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  IQVIA

  Jun 2015 - Jul 2018

  Sr. Central Monitor- Centralized Clinical Operations (In-house CRA) Phase Trails

  ✔Clinical trial Indications – Myocardial Infraction, Psoriatic Arthritis, Acute Myeloid Leukemia, Breast Cancer, Prostate cancer and Crohn`s Disease ✔Clinical trial Phase - Phase II and Phase III Studies ✔Tools: Inform EDC V6, MEDIDATA Rave, Wingspan , CTMS , Roche CTMS , Infosario , IQVIA Clinical analytics, IWRS , Quipment and Clinphone✔Sponsors- CSL Behring, Eli Lilly, Takeda, Pfizer, Janseen and Roche

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  ICON plc

  Jul 2018 - Apr 2020

  Study Start Up CRA (Oncology) Phase Trails

  ✔Clinical Trial Indication: Breast Cancer , Anemia, Anaplastic Astrocytoma and Pulmonary disease ✔Clinical trial Phase: Phase I, Phase II and Phase III✔Tools: ICO trial CTMS, Veeva vault CTMS , Veeva vault TMF , GoBalto Activate and MEDIDATA Rave ✔Sponsor: Pfizer, Johnson and Johnson and JSS clinical research

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  CDSA-THSTI DBT India - Contract

  Apr 2020 - May 2021

  Clinical Research Associate II (Vx) Phase Trails

  ✔Clinical trials Indication: COVID 19 Vaccination and Tuberculosis vaccination✔Clinical trail Phase: Phase II and Phase III✔Tools: e Velos, Clinphone, IP Ven supply , Intralinks and Quipment ✔Sponsor: ICMR and THISTI India *Worked for a Phase III vaccination study with a patient pool of 3000+ for India *Participated in 2 DSMB audits, 3 sponsor audits and 2 QA audits

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  CBCC Global Research

  May 2021 - Sept 2021

  Sr. Clinical Research Associate (Rx) Phase Trails and BA/BE

  ✔Clinical trial Indication: Schizophrenia , Lung cancer and Anemia ✔Clinical trial Phase: Phase IV and PK/PD✔Sponsor: Zydus, Sunpharma and IQVIA ✔Tools: Clinphone, Medidata Rave, Symetric, Clinion , Bioclinica EDC

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  GSK

  Sept 2021 - Dec 2023

  ✔Clinical Asset/ Vaccine projects: Shingrix, Rotarix, Havrix, Synflorix , Seasonal Flu and Boostrix✔Type Of studies: Epidemiology, Value Evidence Outcome & Health Outcome studies ✔Sponsor: Investigator Initiated Studies and Sponsor Collaborative Studies ✔Tools: Veeva Vault, Idea Point, Planisware, Vault CTMS, e Track, PRISM, e COMP, ABAC One trust, SAP eclipse & SAP finance

  • Sr. Study Delivery Lead II (Vaccines) Value Evidence and Outcome studies

    May 2023 - Dec 2023

  • Sr. Study Delivery Lead I (Vaccines) Value Evidence & Outcome Studies and Real World Evidence

    Dec 2022 - May 2023

  • Study Delivery Lead (Vaccines)

    Sept 2021 - Dec 2022
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  Freelance

  Jan 2024 - now

  Senior Trainer

  ✔️Clinical research departmental training and mentoring ✔️Counselling✔️ Contract activities for a Clinical study