Experience

CALYX

• United Kingdom
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Process Specialist

  • Jul 2023 - Present



Tata Consultancy Services

• India
• IT Services and IT Consulting
• 700 & Above Employee

• Clinical Operations Specialist TMF A Study Delivery Specialist

  • Sep 2019 - Jun 2023

  Assisting globally in Clinical trial in Sponsored and supported studies. Study Start-up teleconference with the study team to discuss scope of work in study. Xpress Activation, site initiation process, qc of essencial documents. Updating Clients relevant systems like TMF, CTMS, Veeva Vault for Inspection and Audit readness. Query duscussion, provinding resolution, urgent deliberables on time. Process of KPI for the studies. Supporting in CSR preparation like LOI, SAT, FDA FD report. Archival of Investigator, country, CRA, Site documents as applicable in Clients Trial Master File. Giving Access to study team in relevant Systems as required. Provinding end to end support as when requested. Show less