Nagendra Vedula

About Nagendra Vedula

Clinical Data Management professional with 17+ years of experience delivering…

Experience

1. Clinical Db Design Manager

   IQVIA

   Dec 2021 — Present

   Oversees timely and quality delivery of study deliverables.• 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)• Complete the Study Authorization Form and Trial Capacity Request Form (InForm)• 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 InForm 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.• Identify, escalate and propose solutions for potential quality issues.• Ensure the completion and documentation of all project-specific training, as well as staying current with required Standard Operating Procedures for self and other TDs within the team.• Reviews build timelines and provide input as applicable.• Reviews QIP for own projects, identify out of scope activities if any and inform relevant parties.• Oversee budget and financial performance of multiple TD studies within scope and inform relevant parties as required.• Design Library Source Study and Create Edit Specifications for source study.• Support other TDs in studies based on their therapeutic area expertise.• Mentors and trains new TDs in the team.• May contribute/assist Manager in resource planning for TD projects.• Act as SME for TD role.• Might be working on projects across multiple platforms.• Identify areas for process improvements on an ongoing basis.

Education

• Visvesvaraya Technological University

  B.E

Skills

• Clinical Trials
• Inform
• Electronic Data Capture (Edc)
• Cdisc
• U.s. Title 21 Cfr Part 11 Regulation
• CRO Management
• Clinical Research
• Good Clinical Practice (Gcp)
• Pharmaceutical Industry
• Ich-Gcp
• 21 Cfr Part 11
• Ecrf
• Protocol
• Validation
• Clinical Data Management
• Oracle Clinical
• Pagemaker
• Data Management
• Gcp
• Edc
• Oc Rdc
• CRO
• Crf Design