Data Management Clinical

Rahul Goud Veer, Clinical Data Manager

********@*****.*** 417-***-****

Professional Summary

• Experienced in data management for Phase I, II, and III clinical trials in study set-up, conduct and close out

• Experienced in handling multiple data sources including labs, imaging, and third-party data sources

• Skilled in managing data quality and integrity

• Excellent communication, presentation, and interpersonal skills

• Effective team player with the ability to manage and work independently to ensure deadlines are achieved

Professional Experience

Takeda Clinical Data Manager

Jan 2023 – Present

• Provide support to clinical data management across clinical programs, enabling planning, coordination, and timely delivery

• Manage in-house and out-sourced data management activities for ongoing clinical trials

• Coordinate data Management tasks including protocol review, design of CRFs and edit checks

• Create and/or review Data management plan, Data transfer agreements and CRF completion guidelines

• Assist in developing reports, data listing, and trial-specific data specifications for data review

• Assess the database structures through screen testing and update the database specification for errors

• Perform and approve User Acceptance Testing to validate the database using standard test scripts

• Review Case Report Form for consistency and clarity, generate and resolve data queries

• Support database lock activities as per SOP’s and work instructions Therapeutic Expertise

• Oncology

• Hematology

• Cardiovascular

• Central Nervous Systems

• Medical Devices

Software

• EDC: Medidata Rave, Oracle Inform,

IBL

• Reporting Tools: J-Review

Skills

• MS Word

• MS Excel (VLookup, Pivot table)

Missouri State University Clinical Research Coordinator Sep 2021 – Dec 2022

• Enter clinical data into both Data Fax and DMS data entry systems. Track entered data in clinical database through 1st pass and 2nd pass data entry

• Create and generate various reports in conduct, closeout phase for project team review

• Identify and report the unresolved issues to clinical team which impacts study timelines

• Perform review of clinical data by patient to identify data trends and data inconsistencies that required further investigation

• Serve as the query SME for multiple studies

• Review page verification report, missing pages report and 360 query reports to deliver study status to project team

• QC clinical data to ensure accuracy

HCL Technologies Clinical Data Manager

Jan 2019 – Aug 2021

• Assist in maintenance and closure of study databases

• Provide study progress updates to Clinical Trial Manager and identifies risks and issues

• Generate, maintain data management metrics and track query metrics for allocated projects for status updates

• Assist in design of CRFs, edit checks, CRF completion guidelines and Data transfer agreements

• Perform User Acceptance Testing (UAT) for developing the eCRFs and edit checks

• Perform Data Listings review, SAE reconciliation, External vendor reconciliation and issue queries/follow up with external vendors on outstanding issues

• Utilize listings to identify issues and tracks them until closure to ensure ongoing data cleaning for upcoming deliverables

• Assess ongoing data review to identify trends, issues with study design and data integrity

• Prepare, review and analyze reports, and graphs for consistency and accuracy

• Upload and review the electronic Trial Master File to ensure all data management documents are present

Education

• Master of Science in Project Management, Missouri State University, Missouri, USA (2021 – 2022)

• Bachelor of Business Management, Osmania University, Telangana, INDIA (2016 to 2019)

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