I have 5 years of experience in Clinical Database Designer/Programmer. I have in depth knowledge on study build starts from Protocol Interpretation, eCRF design, ECS preparation, Programming, UAT (eCRF and ECS/DVS/Validation), Custom Function, Postproduction changes and Impact, Migration (Dry-Run and PROD).Known tool : Medrio, RAVE, Veeva, ConferoKey Responsibilities:• Interprets the study protocol.• Design and update the eCRF.• Create and update Edit Specification Document.• Generate specifications for EDC build components (e.g., Rights and Roles, System Settings and Home Page)• Attend the Pre-Design Meeting, Online Screen Review Meeting, Unblinded Data review meeting. • Attend and present comments at the Internal Design Review Meeting. May lead Online Screen Review Meeting.• Facilitate the internal Edit Specification Review Meeting and leads the discussions regarding the Edit Specification Document.• Design the database to collect LLRR data within the RAVE database and ensure Rights and Roles document has appropriate access for Entry and Updates.• Communicate any project risks to the Data Team Lead, including the potential for missing a timeline in the Data Management Project Plan.• Escalate potential quality issues.• Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures.• Reviews build timelines and provide input as applicable.• Reviews UPT for own projects, identify out of scope activities if any and inform relevant parties.• Responsible for multiple study design projects at the same time.• Might be working on projects across multiple platforms.• Identify areas for process improvements on an ongoing basis. Actively take part and contribute towards process improvement initiatives as assigned besides providing suggestions for continuous improvement of processes.
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Clinical Database DesignerIqviaBengaluru, Ka, In -
Clinical Database DesignerIqvia Apr 2023 - PresentBengaluru, Karnataka, India -
Clinical Database Programmer IQuartesian Dec 2019 - PresentBengaluru, Karnataka, IndiaReview protocol and Query preparation on protocol.Building database based upon protocol and Source documents requirements, Review eCRF, eCCG (Completion Guideline), DMP and UAT PlanDevelop specification, test database (eCRF UAT) User, Configuration checklist preparation, Edit Check Specification (DVS) Preparation, Edit Check Programming, Edit Check Testing, Test Script Writing, Test Data Preparation.Postproduction changes and Impact, Migration (Dry-Run and PROD)Maintain and Review QG related documents, Process improvements.Custom Function (Basic level knowledge)
Anamika Jaiswal Education Details
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Biotechnology -
Biotechnology
Frequently Asked Questions about Anamika Jaiswal
What company does Anamika Jaiswal work for?
Anamika Jaiswal works for Iqvia
What is Anamika Jaiswal's role at the current company?
Anamika Jaiswal's current role is Clinical Database Designer.
What schools did Anamika Jaiswal attend?
Anamika Jaiswal attended Vellore Institute Of Technology, Sardar Patel University.
Who are Anamika Jaiswal's colleagues?
Anamika Jaiswal's colleagues are Beadle Tomoko, Revanth Tedlapu, Farrah Z., Rajani Surjith, Andrew Broughton, Avinash Salimath, Poongan Gandhi.
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Anamika Jaiswal
Kolkata -
Anamika Jaiswal
Ex-Sis | Experienced Hr Professional | 7 Years In Recruiting & Corporate Hr | Mba-Hr | Exploring New OpportunitiesDelhi, India -
anamika jaiswal
New Delhi -
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