Tanya K.

WORK HISTORY

EDUCATION

ABOUT TANYA K.

I am a Senior Clinical Operations Professional with over 12 years of experience monitoring Phase II–IV clinical trials across CRO, pharmaceutical, biotech, and medical device environments. My experience includes conducting qualification, initiation, routine monitoring, and close-out visits, ensuring compliance with ICH-GCP, FDA regulations, and sponsor SOPs while maintaining audit-ready clinical trial data.I have extensive therapeutic experience in Psychiatry, CNS, Neurology, Dermatology, and Women’s Health, and I am passionate about supporting investigative sites to ensure high-quality study execution and patient safety.In addition to my monitoring background, I bring strong experience in site enablement and clinical systems, including Clinical Trial Management Systems (CTMS), Medidata Rave, eTMF, and RTSM platforms. I have supported sites and clinical teams with system adoption, process optimization, and operational efficiency, giving me a unique ability to bridge clinical operations and clinical technology.My background also includes Lead CRA responsibilities, mentoring CRAs, reviewing monitoring activities, and supporting overall study quality.I am currently open to Senior CRA, Clinical Systems, and Site Enablement roles where I can contribute my clinical expertise, technical experience, and passion for advancing clinical research.