Hiren Chalodiya, Process Associate

Hiren Chalodiya

Process Associate

TCS (Tata Consultancy Services)

البلد
الهند
التعليم
بكالوريوس, Clinical Research
الخبرات
2 years, 0 أشهر

مشاركة سيرتي الذاتية

حظر المستخدم


الخبرة العملية

مجموع سنوات الخبرة :2 years, 0 أشهر

Process Associate في TCS (Tata Consultancy Services)
  • الهند - مومباي
  • يناير 2014 إلى ديسمبر 2015

 Ensures timely processing, review and validation of clinical data.
 Reviews clinical protocols and eCRF guidelines and eCRF to ensure consistency.
 Responsible for the planning, implementation, and coordination of all electronic and paper data management activities in accordance with study requirements.
 Anticipates and communicates resource and quality issues that may impact deliverables or timelines.
 Recommends and monitors timeliness and communicates project status for assigned work.
 Responsible for updating the Issues List.
 Reconciles the database with IVRS.
 Received formal training on inform 4.6, local lab data reconciliation end to end and RECIST 1.0 criteria.
 Participates in the study start-up process by performing User Acceptance testing.
 Testing of the database, validation procedure testing and provides feedback to the clinical database programmers.
 Liaises with clients and produces study progress reports.
 Doing major activities starting from study start up to DBR and DBF.
 Generation & Resolution of Queries (Query management activity).
 Generation of Listings and various reports.
 Preparing study metrics and metrics charts.
 Doing following Reconciliation processes,
- SAE Reconciliation
- Scan Reconciliation
- Pk Reconciliation
- PGx Reconciliation
- Central lab and Local labs Reconciliation (External Data reconciliation)
 Well versed with form and visit locking & casebook freezing activities.
 Working on SAS checks to resolve discrepancies in eCRF.
 Various Manual listings’ reconciliation with eCRF.
 Preparing various data reconciliation Guidelines & eCRF completion guidelines.
 Communicating with clients and Monitors for study related activities.

الخلفية التعليمية

بكالوريوس, Clinical Research
  • في Gujarat Technological Universities
  • أكتوبر 2013

Specialties & Skills

ICH GCP
Oracle Clinical
Clinical Data Management

اللغات

الانجليزية
متمرّس

التدريب و الشهادات

Post Graduation Diploma in Clinical Research (الشهادة)
تاريخ الدورة:
December 2013
صالحة لغاية:
January 9999

الهوايات

  • Cricket, Reading, Writing, Travelling