VISHNUKUMAR S
Madurai
Summary
Highly skilled Clinical Data Manager with two years of experience in managing clinical trial data. Proficient in data validation, and analysis, ensuring compliance with regulatory standards. Adapt at utilizing various data management systems and tools to streamline processes and enhance data quality. Excellent communication and teamwork abilities, demonstrated through successful collaboration with cross-functional teams. Trained in Excel and in EDC (Medidata RAVE)
Overview
2
2
years of professional experience
1
1
Certification
Work History
Clinical Data Coordinator I
ICON Clinical Research
02.2022 - Current
- Ensure accuracy in clinical data through proactive handling of queries and discrepancies independently
- Coordinate and distribute of essential study documentation, maintaining precise complete study files in adherence with all relevant protocols
- Experience and POC for standard Reconciliations (eCOA/ePRO, eDiary, Biomarker, ECG and LAB)
- Study conduct activities- Query Management, Manual DM Listings, Non – Ascii listings and Missing pages reports
- Creates and Enter Test data for User Acceptance Testing, Edit checks in Post Production Changes
- Track metrics during interim database lock or database cut as per sponsor requirement
- Providing study status metrics to sponsor and study team on regular basis (Weekly/Daily)
- Involved in TMF filing (Trial Master File)
- Involved in Listing Specification revision
- Update study specific tracker on regular basis and performed QC activities for study
- Performed database locking procedures during the closeout phase
- Oversee query distribution and assign queries to the study team
- Provided training to team members on reconciliation tasks and assumed the role of mentor, guiding their development in this area
- Efficiently completes tasks within set timeframes by skillfully prioritizing multiple responsibilities and flexibly adjusts to changing timelines through effective workload reorganization
- Minimizes the need for rework by meticulously following study instructions and seeking clarity on assignments prior to task execution.
- Automated weekly/daily metrics reports through VBA macro
Education
Master of Science in Microbiology -
Thiagarajar College
Bachelor of Science in Microbiology -
Thiagarajar College
Skills
- Good Communication skill
- Teamwork
- Flexible and adaptable to changes and challenges
- Time Management
Co Curricular Activities
Former active member of ‘NSS’ - Thiagarajar college, Madurai and attended one week NSS special camp as a volunteer for a week as social service worker.
Languages Known
- English
- Tamil
- Telugu
- Hindi
Disclaimer
I hereby declare that the information furnished above is true and authentic to the best of my knowledge.
Computer Skill
- MS - Office
- VBA Macro
- Rave database ( 2+ experience)
Certification
- Attended the “Summer training program in Biological science” -The Academy of Sciences, Chennai in association with Department of Biotechnology and Department of Botany, Bharathiar University, Coimbatore.
- Online NPTEL course completion on Current regulatory requirements for conducting clinical trials in India for Investigational new drug.
Timeline
Clinical Data Coordinator I
ICON Clinical Research
02.2022 - Current
Master of Science in Microbiology -
Thiagarajar College
Bachelor of Science in Microbiology -
Thiagarajar College