Venkateswarareddy Allampati

Clinical Research Associate at Admerus Biosciences Private Limited
  • Claim this Profile
Contact Information
us****@****om
(386) 825-5501
Location
Andhra Pradesh, India, IN

Topline Score

Topline score feature will be out soon.

Bio

Generated by
Topline AI

You need to have a working account to view this content.
Join now
You need to have a working account to view this content.
Join now

Credentials

  • Pharmacoviglilance
    Uppsala Monitoring Centre
    Nov, 2019
    - Nov, 2024

Experience

  • Admerus Biosciences Private Limited
    • India
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Clinical Research Associate
      • Nov 2018 - Present

      • Perform the activities for eCTD submission as per Clinical Data Interchange Standards Consortium standards which includes but not limited to Database preparation, aCRFpreparation, Data entry, Review of data entry, Database lock, SDTM Datasets creation, validation of Datasets• Assisting the Lead programmer in creating the ADAM datasets and Define.xml generation • Assist in the coordination of project start-up activities, creation of global programs, tracking spreadsheets, and other required documentation• Maintain all supporting documentation for studies in accordance with SOPs/Guidelines to ensure traceability and regulatory compliance• Provided SAS Programming and analysis support for most of BA/BE Studies and phase I Clinical trials• Use efficient programming techniques to produce derived datasets (e.g. SDTM, ADaM), tables, figures, and data listings of any complexity and QC low-medium complexity derived datasets, tables, figures, and data listings• Generation of TLF’s as provided in the statistical analysis plan• Check own work in an ongoing way to ensure first-time quality• Maintain and expand local and international regulatory knowledge within the clinical industry• Deliver best value and high-quality service

  • Micro Therapeutic Research Labs Private Limited
    • India
    • Research Services
    • 100 - 200 Employee
    • Clinical Research Associate
      • Mar 2018 - Oct 2018

      • Act as Project coordinator for the BA/BE studies and phase I clinical trials conducted at ABS which includes but not limited to Screening of volunteers, check in, Dosing, Check out of the subjects in accordance with the Approved protocol and applicable regulatory requirements• Perform and review of project specification documents such as case report forms (CRFs), study protocol, Informed consentdocuments (ICDs) etc..• Acting as the point of the contact and coordinator for the studies till the successful submission to the QC and/or QA for the review• Archival of the study specific and general documents after the successful completion of the study • Perform online and retrospective data entry for further usage for CDISC based deliverables• Provide responses to the issues raised by the programming team in the data entry through Data Clarification Forms (DCF’S)

Education

  • JNTUA College of Engineering, Anantapur
    B. pharmacy
    2013 - 2017
  • chaitany vidya mandir, badvel
    b.pharmacy, 70%
    2013 - 2017

Community

You need to have a working account to view this content. Click here to join now