CHANDRASEKHARA VUNDI
Atlanta,GA
Summary
Data Management Professional overseeing the data processing, quality control, and reporting of clinical trials for various therapeutic areas to ensure the accuracy, completeness, and consistency of data, and have been in the field for almost ten years. I have experience in using various clinical data management systems, such as Medidata Rave, Oracle Clinical, and ClinTrial. Passionate about applying data management expertise to support the development of innovative and effective treatments for patients.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Senior Clinical Data Manager
Worldwide Clinical Trials
2021.11 - Current
- Gathered, organized, and analyzed clinical data and metadata from multiple data sources
- Reviewed protocol from CDM perspective and provided functional expert feedback
- Oversaw Electronic Data Capture (EDC) build, migration and deployment including creation and execution of User Acceptance Testing plans and test scripts, and implementation of data integrations with external vendor data sources (e.g., IRT, laboratory, imaging, CSSC)
- Created and maintained documentation for templates (DMP, CRF Completion guidelines, Trial Design Document, Edit specifications, Reconciliation guidelines, Report specifications)
- Reviewed the CRF design, annotated CRFs, edit check specifications and DM listings
- Orchestrated with medical/clinical team leads and CRAs to review data and identify inconsistencies
- Performed timely submission and ongoing maintenance of study related 3rd Party (YPrime) Data Acquisition documentation in TMF
- Generated standardized and ad-hoc metrics, reports to facilitate ongoing data review for internal/external team meetings
- Provided guidance and mentorship to less experienced and/or entry-level Associates of Clinical Data Management
- Performed pre-lock and data lock tasks
- Performed archiving of study databases and related documents
- Experienced in Audits performed by various governing agencies
- Experienced in TMF documentation.
Senior Clinical Data Manager
COVANCE
2018.02 - 2021.10
- Responsible for core deliverables such as clinical database design & setup, data collection, Data validation, manual review, and timelines
- Created and maintained Data Management Plan
- Developed and designed Case Report Forms (CRFs)
- Developed Database Build specifications and coordinated database build and testing activities with database programmers
- Defined and tested edit checks
- Ensured all DM activities are performed according to quality standards defined by regulations and standards, SOPs, ICH-GCP guidelines
- Contributed to the development and implementation of edit check specifications and worked with database programmers on edit check development and validation
- Collaborated with internal statistical programming team, Biostatisticians, medical monitor on identifying critical variables in clinical dataset for protocol-specified endpoints
- Reviewed discrepancies in EDC system, monitor/facilitate resolution and closeout or re-query per study guidelines
- Processed/reconciled electronic data received third party vendors, e.g
- Labcorp, Castor EDC
- Planned and created necessary documentation to support internal and external audits
- Collaborated with clinical operations to ensure the data management component of eTMF is maintained throughout the trial.
- Successfully managed multiple clinical trials, ensuring timely completion and accurate data collection.
Clinical Data Manager
PPD
2015.04 - 2018.01
- Directed database design, development, testing and system validation
- Designed and reviewed patient Case Report Forms (CRFs) and tested data capture/entry screens
- Worked with project sponsors, stakeholders, and cross functional team members to define project requirements, scope, risks, organization, and approach
- Developed and maintained data management plans and procedures in accordance with GCP, regulatory requirements, and studied specific protocols
- Defined and monitored clinical trial data flow and quality control (QC) processes in accordance with corporate Standard Operating Procedures (SOPs) and Good Working Practices
- Developed the data validation plan and ensured associated edit checks are completed in accordance with project timelines
- Developed test scripts and performed User Acceptance Testing (UAT) and validation of the database used to collect the clinical data to ensure that the requirements were met for the entry and reporting of clinical data
- Validated and distributed study progress status reports to internal and external study team members
- Partnered with statistical programmers to develop and document data repository schema across data sources
- Ensured all study materials are finalized in eTMF and archived for delivery.
Education
Master of Philosophy in Biotechnology -
Bharathidasan University
IndiaMaster of Science in Biotechnology -
Bharathidasan University
IndiaBachelors in Life Sciences -
Acharya Nagarjuna University
IndiaSkills
- Database setup
- Protocol
- CRF design
- ICH/GCP guidelines
- Data Management Plan
- Discrepancy Management
- SAE Reconciliation
- Vendor Reconciliation
- EDC-Rave
- Oracle Clinical
- Veeva
- SQL
- SAS
- CDISC
- SDTM
Certification
- SAS Certified Base Programmer for SAS 9, 12/17/14
- SAS Certified Advanced Programmer for SAS 9, 12/17/14
Timeline
Senior Clinical Data Manager
Worldwide Clinical Trials
2021.11 - Current
Senior Clinical Data Manager
COVANCE
2018.02 - 2021.10
Clinical Data Manager
PPD
2015.04 - 2018.01
Master of Philosophy in Biotechnology -
Bharathidasan University
Master of Science in Biotechnology -
Bharathidasan University
Bachelors in Life Sciences -
Acharya Nagarjuna University
- SAS Certified Base Programmer for SAS 9, 12/17/14
- SAS Certified Advanced Programmer for SAS 9, 12/17/14
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