OT

Olga T.

Senior Clinical Operations & QA Specialist at Carrick Therapeutics

Olga T. has a wealth of experience in clinical operations, quality assurance, and medical support. Olga began their career in 1993 at the Saratov State Medical University, where they worked in the Department for Dermatological and STD. In this role, they provided medical consultancy services, gave lectures and clinical tutorials, and developed new CPD training programmes. In 2007, they joined the Home Care Support Team at H.S.E. Ireland, where they provided medical support alongside a P.H.N. In 2013, they began working at MSD Biologics (Carlow) as a Material Introduction Analyst and IPT Process Support Specialist. In this role, they were responsible for re-assessing new and approved drug product GMP manufacturing materials, performing gap and change management assessments, and managing Quality Notification deviations, non-conformances, and CAPAs. In 2016, they joined DS Biopharma/ Afimmune as a Clinical Scientist (with CRA, PM and QA experience). In this role, they were responsible for sponsor clinical project management, monitoring clinical Phase I-II studies, medical monitoring, and QA risk assessment. Finally, in 2019, they joined Carrick Therapeutics as a Senior Clinical Operations & QA Specialist and Senior Clinical Operations and QA Associate.

Olga T. has a long and varied educational history. Olga obtained their Medical Doctor degree from Saratov State Medical University in 1987-1993, followed by a Dermatology Residency Program in the same university from 1993-1995. Olga then obtained their Doctor of Medicine (M.D.) degree in Dermatology&Dermatooncology/Physiology from the same university in 1995-1997. In 2014, they obtained a Certificate in Industrial Microbiology and Biopharmaceuticals from Institute of Technology, Carlow. In 2015-2016, they obtained a Post- Graduate Certificate in Clinical &Translational Research from University College Dublin. Additionally, they have obtained several certifications, including QA and GCP Auditing from The Research Quality Association in 2018, HITS from ICS Skills in 2015, ICH GCP from Firecrest - ICON's Innovative Site & Patient Platform in 2015, Care Skills from FETAC (Further Education and Training Awards Council), and Lean Six Sigma Yellow Belt.

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Timeline

  • Senior Clinical Operations & QA Specialist

    February, 2020 - present

  • Senior Clinical Operations and QA Associate

    March, 2019

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