Experience

dicentra

• Canada
• Research Services
• 1 - 100 Employee

• Clinical Research Data Associate

  • Mar 2022 - Present



SIMS Hospital (SRM Institutes For Medical Science)

• India
• Hospitals and Health Care
• 400 - 500 Employee

• Clinical Data Coordinator

  • Dec 2019 - Dec 2020

  • Maintain and update the eCRF application and its components as required for protocol amendments or required post production changes. • Provide general data management support to the project team as needed. • Developed the eCRF layout and corresponding database according to documented trial specific requirements using components from existing libraries. • Created, test and maintain trial specific plausibility and consistency checks. • Created the data extract specifications. • Provided the data transfer specifications, test transfers and load third party data. • Developed database specifications and provide support for outsourced trials • Support Expert Data Manager and other Data Managers in the team for allocated trials within assigned project(s). • Reviewed and provide inputs to global working practices and standards. . • Efficient collaboration with the team from Shared Services to ensure timely deliverables with highquality. • Managing coding activities (MedDRA, WHODrug) for Med His, Conmed’s and AE’s. Show less



SIMS Hospital (SRM Institutes For Medical Science)

• India
• Hospitals and Health Care
• 400 - 500 Employee

• Clinical Data Coordinator

  • May 2018 - Nov 2018

  • Supporting Lead/Trail Data manager in discrepancy management- Raising including manual, closing queries. • Assisted for designing Annotated CRFs, study dynamics • Performed SAE Reconciliation and worked closely with the safety • Imparting training along with coaching and mentoring of new personnel in the organization. • Provide inputs to the resources, schedules and timelines as required • Performed Third party reconciliations like – PK/PD, Immunogenicity, Safety labs • Generated metric reports like Open query reports, Query Age report, Missing visit reports, predicted visit report. • Involved in performing Database testing and writing the test cases for various edit checks • Contributed to the development of study related documents like- DHP, SPS, eCCGs etc. • Attended all study related activities and provided study status updated Show less