Experience

RISU USA, LLC

• Education Management
• 1 - 100 Employee

• Consultant

  • Sep 2018 - Present



Accenture

• Ireland
• Business Consulting and Services
• 700 & Above Employee

• Clinical Data Manager

  • Mar 2007 - Oct 2010

  To perform clinical data cleaning. Ensure the completeness and validity of the clinical trial data that has gone through data entry. Review and resolve data discrepancies identified by the system or through manual checks as identified in the data review plan, SEC with oversight by mentors. Propose CTF to clinical trial sites. Generate and review CRF Summary report and track missing pages. Management of discrepancies as in while it fails. Integration of DCF’s / FCF’s within a turnaround time as defined in the SLA. Generating and working on Interim / Database lock listings as per DRAPP/DRP/CDP checklist within 10 business days from LPLV data entry complete date. Cleaning and preparing the database for the final lock procedures within 45 days from LPLV. Query initiation within the stipulated time as defined in the SLA. Ensure there are no QE / Clinical findings on patients edited. Interact with the client regarding data quality issues. Run I*Review reports to clean the data. Ensure that all spreadsheets sent to client are complete & accurate. Liaising with Client (US) protocol data managers. Communicating any issues in a timely manner to the Client (US team). Provide support to Team Leads and Mentors for timelines and specialized tasks like CTF/FCF integration, spreadsheet completion as and when required. In the above roles, I have worked on projects in the following therapeutic areas: Oncology (PI) Cardio Vascular (PI) Metabolic (PI) Neurology (PI & PII) Immunology (PI) Anti Virology (PI)