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Skills

  • Team building
  • Project organization
  • Data validation and verification checks
  • Team management
  • Adverse event report reduction (69%)
  • Data migration project leadership
  • Relationship development
  • Instruction and training on statistical best practices
  • Clinical data management
  • Data governance implementation

Work Experiences

  • Crafted robust data management plans that ensured alignment with GCP standards, leading to zero critical findings during Austin regulatory audit.
  • Analyzed demographic and adverse event data.
  • Achieved implementation in 2023.
  • Addressed potential protocol deviations.
  • Conducted meta-analysis.
  • Coordinated Study Data Tabulation Model maps with programming.
  • Crafted robust data management plans.
  • Collaborated with biostatisticians.
  • Coordinated real-time data monitoring activities for 6 international trials.
  • Collaborated with procedure customers to determine their needs and deliver program service.

Summaries

  • Senior Clinical Data Analyst with 18 years of successful process improvement and risk assessment experience.
  • Achieved 36% reduction in manual data entry tasks.
  • Senior Clinical Data Analyst is a multi-talented Senior Clinical Data Analyst who is consistently rewarded for planning and operational improvements.
  • Contributed to timely FDA approvals for Tableau.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Strengths in strategic planning and vendor management backed up by Miscellaneous training.
  • Strong ties to framework businesses.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Collaborated with cross-departmental teams.
  • Achieved monitoring efficiency improvements of 29%.

Accomplishments

  • Documented and resolved process which led to initiative.
  • Authored 5 comprehensive data cleaning protocols specifically tailored to multi-phase oncology trials, reducing error rates by 85%.
  • Played a key role in securing regulatory approval for Workday by submitting high-quality clinical data, leading to the approval in 2016.
  • Collaborated with cross-functional teams, including statisticians and project managers, to close clinical trials ahead of schedule by 16 months through streamlined data collection.
  • Developed and implemented new clinical data validation procedures that reduced errors in patient records by 66%.
  • Led the extraction and transformation of patient data for regulatory submissions, cutting final review time by 36%.
  • Championed the development of data integrity assurance protocols, reducing patient data discrepancies by 36% over the course of initiative.
  • Created error-tracking systems for clinical datasets that identified and eliminated 5 potential discrepancies before regulatory submission.
  • Supervised the creation of real-time data dashboards for 8 ongoing trials, enabling faster decision-making and improved outcome tracking.
  • Managed the end-to-end data lifecycle for 16 phase 12 clinical trials, increasing data collection compliance rates by 41%.

Affiliations

  • Association for Computing Machinery
  • Jaycees
  • Society of Clinical Biostatistics (SCB)
  • International Society for Quality in Health Care (ISQua)
  • Professional Certification in Clinical Research (Certified Clinical Data Manager, CCDM) - Northwind
  • Institute of Electrical and Electronics Engineers (IEEE) - Health Informatics Chapter
  • Health Information Management Systems Society (HIMSS)
  • Toastmasters
  • Lions Club
  • International Council of Nurses

Certifications

  • Project Management Professional (PMP)
  • Clinical Research Coordinator Certification (CCRC) - initiative
  • CompTIA Security+
  • Certified Evidence-Based Study Designer - Vantage
  • Certified Clinical Project Manager (CCPM) - system
  • Certified Medical Device Investigator - metric
  • Certified Analytics Professional (CAP) program
  • Cisco Certified Network Associate (CCNA)
  • SQL for Clinical Data Management Certificate - SAP
  • Certificate in Health Information Management (HIM) - Brightline

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