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Skills

  • First Aid/CPR
  • Supervision
  • ICH-GCP Documentation Standards
  • Customer service
  • Database finalization
  • Clinical Trial Database Lock
  • Multilingual Communication Skills for Cross-border Teams
  • Relationship development
  • Managing Multi-Center Trials
  • Communications

Work Experiences

  • Collaborated on cross-functional team reviews to improve trial database design, reducing data ambiguity and improving overall trial efficiency by 22%.
  • Applied strategies across 14 clinical trials.
  • Conducted data reconciliation between multiple data management systems, addressing discrepancies within 5-month timeframe and improving data quality.
  • Contributed to the timely approval of Jira.
  • Designed project-specific coding standards.
  • Conducted data reconciliation between multiple data management systems.
  • Conducted audit in 2023.
  • Had an excellent attendance record and was always on time for work.
  • Designed project-specific coding standards for data operations, reducing data review time by 79% for standard trials.
  • Collaborated with statisticians and analysts to perform reconciliation checks on primary endpoints, ensuring flawless submission packages.

Summaries

  • Clinical Data Associate is a multi-talented Clinical Data Associate who is consistently rewarded for planning and operational improvements.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the initiative business.
  • Achieved 23% faster database builds for initiative clinical trials.
  • Achieved initiative.
  • Accelerated database lock for 14 studies.
  • Clinical Data Associate known for implementing effective quality control procedures that resulted in a 15% increase in analytical accuracy for process research. Skilled in data cleaning and outcome reconciliation.
  • Strong ties to metric businesses.
  • Clinical Data Associate dedicated to automating routine data management tasks, resulting in processing time reductions of 71% and improved accuracy across 7 complex trials.
  • Achieved 69% enhanced trial efficiency.
  • 15 years of experience in data validation.

Accomplishments

  • Collaborated with programmers to develop customized SAS scripts, automating safety data extraction for standard trials.
  • Spearheaded initiatives in data extraction and quality control, contributing to 9 successful product submissions in partnership with regulatory teams.
  • Successfully improved database consistency through the reconciliation of patient-reported outcomes (PRO) data, enhancing trial accuracy.
  • Managed data entry for 9 clinical trials, reducing total entry time by 43% through improved workflows.
  • Created training modules for incoming data associates, improving new hire onboarding efficiency by 55%.
  • Supervised data cleaning initiatives for procedure trials, improving time-to-lock by 3 days.
  • Contributed to the successful regulatory inspection of clinical trials by ensuring accurate and complete data documentation.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Generated customized SAS listings and reports for internal audits, improving transparency and compliance for framework.
  • Played a key role in final data lock and database freezing for 17 safety-critical studies, ensuring regulatory deadlines were met ahead of schedule.

Affiliations

  • European Society of Clinical Microbiology and Infectious Diseases (ESCMID)
  • Rotary International
  • Pharmaceutical Data Science Society
  • Association for Clinical Data Management Professionals
  • American Medical Informatics Association (AMIA)
  • Society of Human Resource Management
  • Regulatory Affairs Professionals Society (RAPS)
  • National Association of Social Workers
  • Association for Computing Machinery
  • Healthcare Information and Management Systems Society (HIMSS)

Certifications

  • Advanced Certificate in Clinical Trials Data Management - process
  • Certified Clinical Research Professional (CCRP) – Brightline
  • Cisco Certified Network Associate (CCNA)
  • Pharmacovigilance and Data Safety Monitoring Certificate - Ironclad Systems
  • Certified Clinical Data Manager (CCDM) - Ironclad Systems
  • Project Management Professional (PMP)
  • Clinical Trials Data Management (CTDM) Program Certification - category
  • Apple Certified Associate (ACA)
  • Regulatory Affairs for Clinical Trials Certification - category
  • Clinical Research Data Proficiency (CRDP) - system

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