SUMMARY
1.5 years of experience as a Clinical Data Coordinator in ICMR project, lead 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
KEYWORDS
CDM, Veeva Vault, Castor EDC, eCRFs, ICH-GCP Guidelines, Onsite Monitoring, Data Cleaning, Data Validation, 21 CFR, DMP, Clinical Trial, Regulatory Affairs, R Coding, Attention to Detail, Technical Proficiency, Communication
“`
This formatted and structured content can be directly published as an HTML post in WordPress.
Cover Letter:
Sure, please provide me with the data that you want me to redact.
Leave a Reply