Bhumika S
Clinical Data Coordinator
Bengaluru
Summary
Detail-oriented and results-driven Clinical Data Coordinator with 3 years of experience in clinical data management, specializing in data review, validation, and discrepancy resolution. Proficient in electronic data capture (EDC) systems such as Medidata Rave and Oracle Clinical, ensuring high-quality data integrity and regulatory compliance. Strong knowledge of GCDMP, ICH-GCP, and FDA/EMA guidelines, with expertise in lab normal range tracking, query management, and database lock activities. Adept at collaborating with cross-functional teams, mentoring junior staff, and optimizing data workflows to support clinical research objectives. Seeking a Senior Clinical Data Coordinator role to contribute expertise in clinical data management and process optimization.
Overview
1824
1824
years of professional experience
5
5
years of post-secondary education
4
4
Languages
Work History
Clinical Data Coordinator
ICON Plc
Bengaluru
02.202 - Current
- Assisted in the development of study protocols, contributing to the design of effective clinical trials.
- Review clinical and third-party data for subjects enrolled in clinical research protocols, ensuring accuracy and compliance based on edit specifications or the integrated data review plan.
- Monitored ongoing studies closely, proactively identifying areas for improvement or increased oversight.
- Coordinated with external vendors to manage outsourced tasks such as lab work or imaging services effectively.
- Responsible for entering local lab normal range data, tracking discrepancies, and identifying and documenting data issues to ensure accuracy and compliance.
- Collaborated with cross-functional teams to ensure timely completion of clinical trials.
- Utilize electronic data capture (EDC) systems, such as Medidata Rave for efficient data entry and validation.
- Train and mentor junior team members, providing guidance on data management best practices and system navigation.
- Assist in database lock and submission activities, ensuring timely and accurate delivery of clean datasets.
Education
Master of Science - Molecular Biology
JSS Academy of Higher Education And Research
Mysuru 04.2019 - 06.2021
Bachelor of Science - Life Sciences
Sarada Vilas College
Mysuru 04.2016 - 06.2019
Skills
Clinical Data Analysis
- Clinical Data Review & Validation
- Data Cleaning & Discrepancy Management
- Query Resolution & Data Reconciliation
- Electronic Data Capture (EDC) Systems (Medidata Rave, Oracle Clinical, etc)
- Lab Normal Range Data Entry & Tracking
- Case Report Form (CRF) Review & Annotation
- Database Lock & Submission Activities
- Adverse Event (AE) & Serious Adverse Event (SAE) Reconciliation
- Clinical Study Protocol Adherence
Technical Skills:
- Electronic Data Capture (EDC) Systems (Medidata Rave, Veeva Vault, etc)
- Clinical Data Management Systems (CDMS)
- Microsoft Excel, Word, and PowerPoint
Regulatory & Compliance Knowledge:
- Good Clinical Data Management Practices (GCDMP)
- ICH-GCP Guidelines
- FDA, EMA, and CDISC Standards
- Clinical Trial Regulatory Compliance
Soft Skills:
- Strong Attention to Detail
- Analytical & Problem-Solving Skills
- Effective Communication & Documentation
Timeline
Master of Science - Molecular Biology
JSS Academy of Higher Education And Research
04.2019 - 06.2021
Bachelor of Science - Life Sciences
Sarada Vilas College
04.2016 - 06.2019
Clinical Data Coordinator
ICON Plc
02.202 - Current
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