Vaishnavi Yeshirao
Clinical Data Management
SUMMARY
1.5 years of experience as a Clinical Data Coordinator in ICMR project, leading end-to-end processes of the clinical study site including eCRFs, ethical submissions, and ensuring data integrity. Passionate about CDM roles.
SKILLS
– CDM
– Veeva Vault basics
– Castor EDC
– eCRFs
– ICH-GCP guidelines
– Onsite Monitoring
– Data Cleaning
– Data Validation
– 21 CFR
– DMP
– Clinical trial
– Regulatory affairs
– R coding (intermediate)
– Attention to detail
– Technical proficiency
– Communication
CERTIFICATIONS
– Principles and Practice of Clinical Research (NIH)
– Clinical data management
– Regulatory affairs
– Mini – Course EU MDR
EXPERIENCE
Project Technical Support III (ICMR Ad-hoc)
LTMMC | Mumbai
03/2023 to 09/2024
– CTM
– eCRFs
– Data Accuracy and Management
Key Achievements
– Enrollment Management success: Managed 100+ patient enrollments with 90% follow-up compliance
– IRB submissions: Contributed to ethical submissions with IEC and project communication with sponsor
– Organization and quality control: Oversaw end-to-end to life-cycle of the trial independently
EDUCATION
Master of Science, Microbiology
HBSU, Mumbai
2020 – 2022
Bachelor of Science, Microbiology
University of Mumbai
2017 – 2020
LANGUAGES
English | Hindi | Marathi
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Cover Letter:
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