Kavindi Balasinghe

Experience

• 

  OKI International

  May 2018 - Feb 2019

  Teacher(Chemistry)

  -Teaching Cambridge Ordinary Level Biology, National Syllabus Ordinary Level Science

• 

  MAS Holdings

  Feb 2019 - Aug 2019

  Quality Assurance Intern

  -Project - Minimization of lead time and cost of testing in Quality Assurance Laboratory- Quality assurance in textiles.-Product development and fabric testing.-Lean Manufacturing and Chemical Management-Member of BEPZ Toastmasters, Toastmasters International.

• 

  RemediumOne

  Dec 2019 - Dec 2020

  Executive - Business Development and Regulatory Affairs

  -Handling safety reporting and regulatory submissions to local regulatory authorities and ethics review committees.-Maintain regulatory and safety documentation of clinical trials.-Coordination with CROs and other stakeholders in the clinical research industry.-Track project progress and maintain periodic status reports.-Scientific writing, publications, and business development.

• 

  Syneos Health

  Jun 2021 - now

  -Review and adhere to the requirements of study-specific Clinical Data Management Plans for assigned projects.-Performs User Acceptance Testing (UAT) for data entry screens, edits and assigned data review listings, all different roles used in the study.-Review of discrepancy (edit check) output, validation listings and perform query management as per Data Validation Specification (DVS) /Data Management Plan (DMP). -Review data quality by performing DM, SAS, Manual listing,SAE reconciliations,Vendor reconciliations and perform data cleaning as per DVS/DMP. -Performs DM quality review and/or other internal QC checks as required for applicable EDC systems.-Maintain study documentation in the Data Management Study File (DMSF) & assist with study documentation archival.-Track project progress and maintain periodic status reports.-Coordination with internal stakeholders and assisting internal/external audits as required. Show less

  • Clinical Data Associate II

    Jul 2024 - now

  • Clinical Data Associate I

    Jun 2021 - now