Shalom Manne

About Shalom Manne

Passionate and results-driven Clinical Research Professional with over 6 years of…

Experience

1. Clinical Trial Associate - Oncology

   AstraZeneca

   Mar 2023 — Present · US

   Operational responsibility for the correct set-up and maintenance of the local eTMF and ISF including document tracking in accordance with ICH-GCP and local requirements.• Ensures essential documents under their responsibility are uploaded in a timely manner to maintain the eTMF “Inspection Readiness”.• Ensures that all study documents are ready for final archiving and completion of local part of the eTMF and supports the CRA in the close out activities for the ISF.• Contributes to electronic applications/submissions by handling clinical-regulatory documents according to the requested technical standards i.e, Submission Ready Standards (SRS), supporting effective publishing and delivery to regulatory authorities.• Responsible for site communications and other portal management.• Compiling shipment request to laboratory vendors, track and ensure samples received at vendors, follow up with sites/CRO for missing samples, and prepare/provide summary reports to clinical trial manager as requested. • Assist in monitoring timelines, budgets, and clinical trial materials and supplies. • Supports the set-up and management of clinical trial supplies and biosample management where needed (drug product, ancillary and other).• Assists in external training activities (suppliers, clinical sites etc.).• Assists in the management of trial completion activities, including data review, database lock and trial closeout.• Retrieving missing documents from site ISF.• Running and analyzing reports from multiple systems• Responsible for Periodic QC, FD, IRB and TMF reconciliations.• Handle requests for CTMS updates• Support the CRA in the maintenance and close out activities for the ISF.

Education

• Sacred Heart University

  Masters in Healthcare Informatics

• Osmania University

  Bachelor's degree