SAMEER BHAKSHI
Clinical Research Professional
Bengaluru,Karnataka
Summary
Dedicated Data Management Analyst in the Clinical Data Management department at ACCENTURE. Meeting up all the project specific demands. Active team player and committed to meet up the deadlines. Technologically savvy and focused Clinical Data manager with strong background in advanced data management and troubleshooting skills . Effective in developing and optimizing data systems to meet customer needs.
Overview
5
5
years of professional experience
Work History
Data management analyst
ACCENTURE RESEARCH SOLUTIONS PVT LTD
BANGALORE, Karnataka
08.2019 - Current
- Review local lab data entered in database and perform discrepancy management activity on discrepant data.
- Identify missing normal reference ranges and incorrect reference ranges for local lab data entered in database and perform LAC assignment criteria.
- Identify missing samples in central lab data transfer as well as the discrepancy in the central lab data transfer and send the missing samples details and discrepant data details to central lab vendor in Vendor Missing sample log and Vendor data issue log document.
- Perform discrepancy management activities for the loaded central lab vendor data.
- Vendor Data Reconciliation.
- Data cleaning/validation and reconciliation of external data (Lab/SAE).
- Creating reports, listings, metrics and other output as required during the project.
- Responsible as contact person for the External source of electronic data transmissions.
- Communicating to vendors and client problems involving data transfers, data point issues and validation issues.
- Ensuring electronic vendor data contains all protocol specified parameters, is in correct format and data populates to the specified fields and patients correctly.
- Assists with review of data discrepancies generated by study specific edit checks for External data and perform the subsequent query management process in resolving the data issues.
- Providing accurate data acquisition, data validation and reconciliation to the clinical studies and shall ensure quality standards per SOPs and ICH-GCP.
- Review the standard set of SPOTFIRE report & J-Review listings.
- Raising & closing the queries in EDC (RAVE, Inform 5.5, 6.1 & Oracle Clinical).
- Train and mentor new team members.
- Data Quality and Discrepancy Management.
Medical Surveillance Specialist
IQVIA RDS (INDIA) PVT LTD
BANGALORE, Karnataka
06.2017 - 08.2019
- External data reconciliation.
- Data Quality and discrepancy management.
- Manual Review & Query Management.
- Monitor and evaluate laboratory/EKG results daily from sponsor designated central laboratory.
- Work with central laboratory staff to facilitate appropriate monitoring and reporting of subject laboratory results.
- Review safety lab listings identify the discrepancies, abnormal/critical values and raise queries using project specific clinical data trial and data management tools.
- Discrepancy management- Review, generate and close queries.
- Review, evaluate & monitor LAB & ECG results on daily basis for central & local lab.
- Contacting sites & sponsors for abnormal results.
- Discrepancy/Query Management: Generation of queries for true lab alerts (abnormal result), discrepancy result, missing result, lab name not selected issues and resolution of queries after correction.
- Raising & closing the queries in EDC (RAVE, Inform 5.5, 6.1 & Oracle Clinical).
- Attending medical calls with sponsors and medical advisors.
- Assisting in Startup and Closeout activities.
- Making up presentation for safety medical calls.
- Data entry, LLR entry & Data Cleaning activities.
- Organizing team fun activities and team outings.
- Data Management Plan maintenance.
- Analyzing data, identifies trends; prepares data tables for reports.
- External data handling.
- Vendor Data Reconciliation Local labs reconciliation.
- Attending investigator/study start-up meetings as requested by Sponsor.
- Assist in the preparation of study specific documentation.
Lecturer and Research Coordinator
APOLLO MEDSKILLS PVT LTD
10.2015 - 10.2016
- Coordinating work in the laboratory to ensure efficient use is made of expensive pieces of equipment.
- Teaching Microbiology, microbiological techniques its practical applications.
- Running trials of experiments prior to classes and then demonstrating techniques for experiments.
- Preparing equipment and chemicals before lessons - from test tubes to state-of-the-art microscopes.
- Rewards and Recognition.
- Appreciation from Medical Advisor.
- Bravo” Award |2019 from IQVIA.
- In Training and compliance Team for a Year.
- Mentored 7 people.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Education
Master's - Biomedical science
University of East London
Bachelors of Science - Nursing
Kempegowda Institute of Nursing science
Pre-University - undefined
PES PU College (PCMB)
Quote
Judge a man by his questions rather than his answers.
Voltaire
Skills
Microsoft excel
undefinedTimeline
Data management analyst
ACCENTURE RESEARCH SOLUTIONS PVT LTD
08.2019 - Current
Medical Surveillance Specialist
IQVIA RDS (INDIA) PVT LTD
06.2017 - 08.2019
Lecturer and Research Coordinator
APOLLO MEDSKILLS PVT LTD
10.2015 - 10.2016
Pre-University - undefined
PES PU College (PCMB)
Bachelors of Science - Nursing
Kempegowda Institute of Nursing science
Master's - Biomedical science
University of East London
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