EDC
Joydeep Chakraborty
Pune,MH
Summary
Experienced clinical research professional currently in the final semester of a Master’s degree in Clinical Research, maintaining a CGPA of 9.00, with a post-graduate focus in Clinical Research and Clinical Data Management, supported by a bachelor’s degree in Biotechnology. Demonstrates hands-on expertise in clinical trials, drug research, and regulatory compliance. Skilled in protocol design, clinical documentation, trial monitoring, and data handling, with practical proficiency in EDC, CTMS, and clinical data management systems. Actively seeking an opportunity to apply analytical, regulatory, and operational skills to deliver meaningful impact within clinical research and development initiatives
Overview
1
1
years of professional experience
4
4
Certificate
3
3
Year of post-graduate education
Work History
Clinical Research Coordinator
JSS Medical Research Pvt. Ltd
09.2023 - 02.2024
- Efficiently managed the post-marketing study of four Himalayan baby products at Imperial Multispecialty Hospital, ensuring adherence to regulatory compliance and guidelines
- Collaborated closely with the Principal Investigator (PI) to prioritize baby safety, implementing protocols and procedures to safeguard participants throughout the study
- Successfully completed subject enrollment and follow-up visits one month ahead of schedule, demonstrating efficient project management and coordination skills
- Conducted efficient Electronic Data Capture (EDC) entry, ensuring accurate and timely recording of study data while maintaining compliance with regulatory requirements
- Liaised with regulatory authorities and ethics committees to ensure timely approvals and ongoing compliance throughout the study duration.
Junior Process Associate
Innoplexus Pvt. Ltd
01.2021 - 07.2021
- Contributed to CURIA Cancer Patient App development by validating data and extracting insights
- Experienced with Proteins, Drugs, Gene, MoA, and Literature databases
- Conducted thorough data validation and employed data mining techniques to extract meaningful insights for cancer patient needs.
Education
Master of Science - Clinical Research
08.2024 - Current
Current CGPA : 9.00
Advanced Post Graduate Diploma - Clinical Research And Clinical Data Management
03.2024
- Final Grade: 77%
Bachelor of Technology - Biotechnology
04.2020
- Final Grade: 64%
Skills
- MS Excel
- MS Word
- Power Point
- EDC (Electronic Data Capture)
- SQL
- eTMF
- Informed Consent Process
- Clinical Data Management
- Regulatory Compliance
- GCP (Good Clinical Practice)
- Case Report Form (CRF)
- Adverse Event Reporting
- ICH Guidelines
- FDA Regulations
- Data cleaning
- Data Reconciliation
Certification
- Certification in Clinical Research and Clinical Data Management - BCRI, Bangalore (Dec 2021 - Mar 2022)
- Food quality Control Intern - Nourish Organics Pvt Ltd.,Gurgaon (Sep 2022)
- ORACLE CLINICAL internship with Think-i and Cliniminds (Sep 2023- Dec2023)
- Global Volunteer on Model United Nations' 8th global goal, AIESEC Egypt - 2019
Software
CTMS
Microsoft Excel
SQL
REDCap
Veeva Vault
MS Word
PowerPoint
Outlook
Languages
English
Advanced (C1)
Hindi
Bilingual or Proficient (C2)
Bengali
Bilingual or Proficient (C2)
Timeline
Ajeenkey DY Patil University - Master of Science, Clinical Research
08.2024 - Current
Clinical Research Coordinator - JSS Medical Research Pvt. Ltd
09.2023 - 02.2024
Junior Process Associate - Innoplexus Pvt. Ltd
01.2021 - 07.2021
Cliniminds Institute of Health Science Training And Management - Advanced Post Graduate Diploma, Clinical Research And Clinical Data Management
SRM University - Bachelor of Technology, Biotechnology