Sammitha Vijaya Rama Raju
Clinical Data Manager
Hyderabad
Summary
Data management professional with extensive experience in organizing and analyzing data to support strategic decision-making. Known for collaborative skills and flexibility in dynamic environments. Expertise in data governance and database management.
High-performing professional with extensive experience managing large-scale, complex databases. Skilled in database management systems. Strong understanding of database design and data modeling with excellent troubleshooting skills. Smart and committed to staying up-to-date with new technologies and advancements.
Overview
11
11
years of professional experience
12
12
years of post-secondary education
3
3
Languages
Work History
Lead Data Manager
IQVIA RDS
10.2021 - Current
- Responsible for managing delivery of Lead Data Manager (LDM) services for study start-up conduct and close-out and maintenance /updates via the Change Control Process for the Clinical Trial Database
- Works with key stakeholders to develop a fit for purpose database
- Provides technical advice and solutions to solve problems and improve efficiencies including root cause analysis for database design during the start start-up Phase
- Serves as the main point of contact for internal and external team members and maintains good working relationships and strong communication skills
- Completes all DM related tasks per customer standard operating procedures, work instructions, good clinical practice, and other necessary controlled documents
- Maintains eTMF study documentation with high quality and is audit/inspection ready
- Leads suggestions in process improvements and solutions to DM team/department
- Provides Support and mentor/train/development to the new team members
- Creates documents which include Data Requirements Table, ALS, SDRS, Data review Plan and eCRF completion guidelines
- Creating test scripts and performs UAT of Database and DMP checks
- Identify and resolve the Database issues during the database UAT phase
- Creating and maintenance of DMP edit checks
- Author DRT with CST and initiate the review and approval of document
- Obtain approvals for any deviations/updates to existing standards
- Conduct walk through of database functionality (forms, fields, restrictions, dictionary, matrix, calendar, etc.) with the Lead Data Manager so they are familiar with the build of the study
- Performs discrepancy management with Study Data Quality Plan and within timelines
- Ensuring interim and final database is locked as per timelines with accuracy
- Review of Missing Visit Reports for all vendor transfers being received (inbound)
- Review the study status of all vendor issue logs (as applicable) on the Vendor Issue Log Tool and take appropriate clean up action if required and send vendor issue log to the vendor containing monthly issues
- Non-Site User Access Change Report (Rave) review and update RADDMT as proof of completion
- TMF Quarterly QC of TMF Quality
- Inspection Readiness Review
- Attend Monthly IPRM (Internal Project Review Meeting)
- DMP Quality Checks Report (DMPQCR) Review (due at each DMP up-version)
- DES up-version release review
- Address CAPAs within the required TAT/ in a timely manner
- Errata Log review (as applicable)
Business Process Lead
TATA Consultancy Services
02.2020 - 10.2021
- Query Management and data cleaning
- Creating test scripts and performs UAT of Database and DMP checks
- Identify and resolve the Database issues during the database UAT phase
- Creating of eCRF specification guidelines
- Creation of Study status reports
- Review of manual checks according to Data Review Plan
- UAT of email alerts
Junior Data Analyst
Cognizant Technology Solutions
01.2017 - 12.2019
- Allocating and Actioning Queries on daily Basis (Discrepancy Management)
- Review of local lab reference range documents
- Data entry of Local lab reference ranges
- Identifying the issues and discussing issues with LRR POC
- Creation of Study status reports
- Third Party reconciliation
- SAE reconciliation
- Review of Manual Checks
- Performing J-review for the assigned SAS checks
- Attending and discussing open issues during study Status calls
- Completing assigned trainings
Clinical Data Analyst-1
Clinztech Solutions
07.2014 - 12.2016
- Working on Answered queries
- Performing data entry for the lab reference documents
- Review of Manual checks
- Lab data reconciliation
- Creating of IPD checks
- Creation and review of DMP checks
- Creating mock-up CRF’s as per the study requirements
- 100% compliance to timely completion of the client and organizational required trainings
Education
Master of Science - Pharmacology
Jaipur National University
Jaipur 04.2001 - 01.2013
Skills
- Skilled in Medidata Rave Platform
- Excel Spreadsheet Management
- Experienced with MS Word
- Visual Communication Skills
Professional Accomplishments
- Worked on Complicated and high priority studies and successfully completed 2 RTP and 8 Migrations with high quality.
- Appreciation and rewards provided by Management on completing the study tasks within client agreed timelines.
- Recognized by Project Management leads and DMQL for execution of lab data in achieving the project deliverable milestone.
- Appreciations received from Local study leads and Team manager on handling the tasks assigned effectively and keeping the issues to zero.
Disclaimer
I hereby declare that the above information furnished is true to the best of my knowledge and belief.
Personal Information
- Father's Name: Sammitha Srinivasa Raju
- Date of Birth: 10/21/89
Timeline
Lead Data Manager
IQVIA RDS
10.2021 - Current
Business Process Lead
TATA Consultancy Services
02.2020 - 10.2021
Junior Data Analyst
Cognizant Technology Solutions
01.2017 - 12.2019
Clinical Data Analyst-1
Clinztech Solutions
07.2014 - 12.2016
Master of Science - Pharmacology
Jaipur National University
04.2001 - 01.2013
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