Hiren Chalodiya

Process Associate at TCS (Tata Consultancy Services)

• India - Mumbai
• January 2014 to December 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.