Experience

COVANCE INDIA PHARMACEUTICAL SERVICES PRIVATE LIMITED

• 1 - 100 Employee

• Clinical Data Lead 1 Assistant Manager

  • Mar 2018 - Present

  • Ensuring the completeness, consistency and quality of the clinical trial data with all applicable procedures. • Generate, resolve and track queries to address problematic data identified during data review activities and apply proper modification / correction to the database. • Discrepancy Management – Manual and System Query generation, Sending Queries to the sites, reviewing and Closing the answered queries. • Perform reconciliation of the clinical and safety databases, reconciliation of central laboratory and/or third party vendor data and aggregate review of clinical data by patient, site, and/or project to identify data trends (patient safety, compliance, etc.), and/or data inconsistencies that require further investigation. • Apply quality control procedures and checks to ensure data quality standards are achieved. • Serve as a reviewer of project documents such as protocols, CRFs (or eCRFs and eDiary), CRF (eCRF) completion guidelines, etc. • Assist with the development of [Global] Data Management Plans and Quality Management (QM) Plans that will deliver accurate, timely, consistent, and quality clinical data. • Interact and collaborate with other project and specialty team members (clinical, programming, CDM technical support, etc.) to support the set-up, maintenance, andclosure of the data management aspects of the project to ensure consistent, cohesive data handling and quality. • Worked on Xcellerate Tool (Discrepancy Management – Manual and System Query generation, Sending Queries to the sites, reviewing and Closing the answered queries.) • Working On Page review and on daily basis and raise queries when required accordingly. • Understanding CRF Completion Guidelines. • Identify and appropriately address data discrepancies in the clinical data via computerized edits and manual checks/listings (Manual Listings). • Preparations of Weekly Status Reports on weekly basis, updating the Project Review Tracker. • Work Allocation to be distributed to the team. Show less



Quintiles

• Spain

• Clinical Data Coordinator

  • May 2011 - Mar 2018

   As Clinical Data Coordinator:  Worked as a Data reviewer for the assigned studies from Start up to Close out of the study.  Involved in all the start-up activities- CRF creation, edit specifications, data extract, listings, and/or validation plan.  Review and understand all the study documents (Protocol, IB, eCRF completion guidelines etc.) and the study timelines.  To ensure error free & high quality data with no errors in the activities.  Performed Vendor data Reconciliation.  Review the resolved discrepancies and close associated queries as appropriate  As Validation Team Lead:  Leading all the Start-up activities.  Understanding protocol and attending online review meetings along with all stake holders.  Review of eCRF, edit check specifications, writing test cases, QC of test cases.  Assigning and coordinating all the start-up activities to the team.  Testing the EDC build.  Testing the programmed edit checks and programming activities as assigned.  Testing the edit checks in the HP Quality centre.  eCRF’s Form level testing using ALS (Architect Loader Spreadsheet).  Performing the data validation with SDTM standards.  Understanding of CDM standards and processes.  Understand and comply with core operating procedures and working instructions Show less