Ramani Gali

FMG, CCRC 281-***-**** ad4q53@r.postjobfree.com

Summary

Experienced clinical research professional with over 12+ years of expertise in the industry. Proficient in management, site operations, regulatory affairs, and quality assurance. A valuable asset in coaching research professionals to develop as trial management leaders.

Experience

DM Clinical Research

Site Manager

2022-Present

• Mentor and guide staff in their training to realizetheir full potential as leaders and to cultivate a positive company culture.

• Oversee all ongoing trials focusing on study enrollmentgoals and capturing quality data, resulting in increased site operational efficiency.

• Liaisons with principal investigators, site staff,and sponsor representatives to ensure smooth site operation.

• Developed the process of a regulatory tracker to improve the flow of add-on staff at site.

Study Manager

2020-2022

• Managed 15+ clinical trials from study start toclose-out in compliance with applicable regulations and SOPs.

• Collaborated with quality assurance to maintainmodest audit readiness, ensuring compliance and operational excellence.

• Enforced mock-runs prior to study start in orderto reduce data entry errors, thereby elevating the accuracy and quality of DM clinical trials.

• Demonstrated understanding of clinical trial activitiesin adherence to GCP guidelines by achieving ACRP CCRC credential.

Clinical Research Coordinator

2018-2020

• Successfully enrolled 218 subjects and achievedTop 3 for site enrollment in C Diff trial.

• Collaborated with CRAs at their monitoring visitsto discuss the adherence of protocol guidelines at the site level.

• Utilized trackers and spreadsheets to keep up-to-dateinformation on hand.

• Managed VLA1553-301 trial wherein we were awardedanother follow up trial, VLA1553-302, and paved my path of a Study Manager. Ramani Gali

FMG, CCRC 281-***-**** ad4q53@r.postjobfree.com

Endocrine Consultants of Texas

Clinical Research Coordinator

2010-2018

• As a single CRC, handled 10 clinical trials ata private practice overlooking trials from initiation to close out.

The Oxford Dental College and Nursing

Teaching Assistant

1999

• Actively facilitated anatomy laboratory sessions,provided guidance to students, and assisted in the execution of experiments and projects.

• Gained valuable expertise in anatomy education,laboratory management, and student mentorship.

Education

JSS Medical College Mysore, India

Bachelor of Medicine, Bachelor of Surgery (MBBS)

1999

Skills

Languages:English, Hindi, Telugu, Kanada

Technical:Microsoft Suite, Spreadsheets, Trackers,Dashboards, Clinical Data Collection, Management and Monitoring, Administration Working:Time Management, Communication, Collaboration,Adaptive, Fast Learner Clinical Trial Experience

Therapeutic Trials:Diabetes Mellitus, Hypertension,Hypercholesterolemia, Growth Hormone, Osteoporosis, DM With CKD, DM with CVD, Gout, Insomnia Vaccine Trials:COVID-19, C.Diff, RSV, Herpes Zoster,Varicella, Epstein Barr Virus, Anthrax, Chikungunya, Influenza

Sponsors:Pfizer, Emergent BioSolutions, Sanofi, Moderna,Novo Nordisk, Eli Lilly, AstraZeneca, Bristol Myers Squibb, New Amsterdam, Valneva, Altimmune, Alnylam, Boehringer Ingelheim, Janssen, Teva, Medicago, Novavax, Idorsia, Genkyotex, Merck CROs:IQVIA, Icon, Parexel, PPD, Syneos Health, Medpace, Laboratories:ICON iSite, Eurofins, PPD Preclarus,VRD, Q2, Labcorp, Medpace eCOA:TrialMax, Signant Health, Study Hub

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