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Skills

  • SOP compliance
  • Relationship development
  • Discrepancy management
  • Clinical trial phase oversight
  • MS Office
  • Data analysis for FDA submissions
  • Data audit and correction
  • Data-driven decision making in clinical research
  • Generation of customized data reports
  • Solution deployment

Work Experiences

  • Conducted comprehensive data audits, identifying and resolving over 16 major errors during category.
  • Had an excellent attendance record and was always on time for work.
  • Contributed to a 64% reduction in resource costs.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Looked for industry trends on social media and through online sources.
  • Applied metric tools for data analysis.
  • Created detailed user guides for EDC systems.
  • Collaborated with biostatisticians.
  • Coordinated Study Data Tabulation Model maps with programming.
  • Decreased manual review errors by 67%.

Summaries

  • Hardworking and pragmatic, with a methodical approach and strong attention to detail.
  • Clinical Data Specialist proficient in GCP.
  • Clinical Data Specialist with demonstrated success in supporting cross-trial quality control efforts, improving data consistency and reducing errors by 52%.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the system business.
  • Conducted clinical data analysis.
  • Dedicated to improving clinical data management, organization, and reporting through superior research, investigation, and project management skills.
  • Achieved a 75% reduction in discrepancies.
  • Clinical Data Specialist with success in quality control.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Results-oriented, precise, and systematic, with an aptitude for quick learning and collaboration.

Accomplishments

  • Engineered a workflow to track data entry performance, reducing query resolution time by 18% and improving the overall database lock timeline.
  • Reduced time-to-database lock by implementing enhanced data cleaning procedures, removing 13 major discrepancies across 16 studies.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Developed a process automation script using Workday that slashed data cleaning time by 33%, significantly reducing the time to FDA submission.
  • Instrumental in the design and implementation of query handling workflows that reduced the turnaround time for resolving queries by 22%.
  • Extracted, transformed, and validated clinical data, contributing to the success of metric clinical trials for a novel treatment in initiative.
  • Generated bespoke study reports for stakeholders, providing valuable insights through consistent data visualization and analysis.
  • Participated in the review of procedure submissions, ensuring all data validation rules were met, contributing to 4% of submissions accepted on first-pass.
  • Managed data surveillance activities for 16 clinical studies, identifying anomalies which helped reduce discrepancies by 40% %.
  • Automated routine EDC data reporting tasks using Workday, reducing manual efforts by 79% and freeing up 7 labor hours per week.

Affiliations

  • American Marketing Association
  • National Association of Social Workers
  • Society of Women Engineers
  • Data Science Certification Council Awardee
  • Certified Data Management Specialist through procedure
  • Society for Clinical Data Management (SCDM) Member
  • Contributor to FDA Global Data Standards Group
  • Toastmasters
  • American Society of Safety Professionals
  • Reviewer for Journal of Clinical Data Management

Certifications

  • ICH GCP for Clinical Data Management Professionals - Lakeside Partners
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Data Privacy Solutions Engineer (CDPSE) - Ironclad Systems
  • Clinical Trial Monitoring Professional Certification - Harbor & Co.
  • Microsoft Certified Systems Engineer (MCSE)
  • Data Protection and Compliance Certification - procedure
  • CompTIA Security+
  • Health Information Technology Certification - Vantage
  • Certified Clinical Data Scientist (CCDS) - Harbor & Co.
  • Data Management & Analytics (DMA) for Clinical Trials Certification - Beacon Labs

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