Chanchal Chatterjee
Bengaluru
Summary
Clinical data management professional with 5 years of experience in clinical data management and eTMF filing. Managed data management deliverables across multi-phase clinical trials spanning multiple therapeutic areas and EDC platforms. Led cross-functional collaboration for issue resolution and ensured compliant data quality within defined timelines.
Overview
1
1
Language
7
7
years of professional experience
Work History
Senior Clinical Data Associate
Novotech
Bengaluru , India
07.2024 - Current
- Managed procedures for building and testing EDC database, ensuring functionality and compliance with study requirements.
- Maintain the data quality throughout the trial and escalate problems to attention of the Data Manager Lead or Project Manager.
- Start-up activities : Creating Edit Check Specification (ECP), Test cases writing, drafting CRF completion guideline (CCG), drafting Data Transfer Agreement (DTA), Database validation, User Acceptance testing (UAT)
- Study Conduct Activities : Data discrepancy review/query resolution, Creation of SAS specification for data cleaning, external data reconciliation, SAE reconciliation, Medical Monitor Query management, Protocol Deviation reconciliation, User Access reconciliation.
- Study Close-out activities: Execution of all close-out activities. Review and sign off on all data management plan (DMP) documents, post lock activities.
- Prepared regular study metrics and shared with stakeholders, including clients; attended internal and client calls to update on study progress and address data issues.
Senior Process Associate
Tata Consultancy Services
Bengaluru , India
06.2023 - 07.2024
- Startup : User Acceptance Testing
- Conduct : Data review (Query and listing review), Vendor data reconciliation.
- Closeout : Database freezing
Trainee Junior Data Analyst
Cognizant
Kolkata , India
09.2021 - 04.2023
- Worked on query resolution
- Data cleaning process by listing review.
- Site specific Local Lab Normal Ranges (LNR) entry for Rave.
Patient Advocate
Navya Technologies Pvt Ltd
Bengaluru , India
04.2020 - 09.2021
- Involved in treatment plan preparation for Oncology patient.
- Transcribes patient medical history accurately during telephone intake calls.
- Patient query resolution regarding treatment plan.
Education
Master of Science - Biochemistry and molecular biology
Pondicherry University
Pondicherry Bachelor of Science - Biochemistry
University of Calcutta
Kolkata, IN-WBSkills
- Clinical data management
- Data reconciliation, data review
- eTMF filing in Veeva vault
- Experience in EDC platforms: Medidata Rave, Veeva Vault, InForm
- Therapeutic area experience : Oncology, Dermatology, General medicine, Vaccine study (Covid-19)
Languages
English
Proficient
C2
Accomplishments
- Promoted to Sr Clinical data Associate in Novotech
Timeline
Senior Clinical Data Associate
Novotech
07.2024 - Current
Senior Process Associate
Tata Consultancy Services
06.2023 - 07.2024
Trainee Junior Data Analyst
Cognizant
09.2021 - 04.2023
Patient Advocate
Navya Technologies Pvt Ltd
04.2020 - 09.2021
Master of Science - Biochemistry and molecular biology
Pondicherry University
Bachelor of Science - Biochemistry
University of Calcutta