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Skills

  • Discrepancy management
  • Procedure equipment
  • Attention to detail
  • Communications
  • Business operations
  • Clinical Trial Lifecycle Management
  • Clinical Study Coordination
  • Customer service
  • Test script writing
  • Project organization

Work Experiences

  • Created standardized data management plans, reducing discrepancies by 66% across 7 international trials.
  • Achieved zero discrepancies during audit preparation.
  • Saved $10 by putting in place cost-cutting measures that addressed long-standing issues.
  • Decreased time to data submission by 82%.
  • Collaborated with cross-functional teams to coordinate data transfers that led to a 25% faster study closeout for process.
  • Coordinated multiple critical tasks across data management.
  • Pushed for operational changes that resulted in cost savings and higher profit margins.
  • Applied improvements in 8 clinical trials.
  • Coordinated critical data transfers for category.
  • Transported HubSpot to three years customer locations.

Summaries

  • Coordinated large-scale clinical trials.
  • Cut data discrepancies by 38%.
  • Contributed to a 25% faster study closeout for critical trials.
  • Decreased query resolution times by 72%.
  • Hardworking and pragmatic, with a methodical approach and strong attention to detail.
  • Strengths in strategic planning and stakeholder engagement backed up by Miscellaneous training.
  • Delivered high-quality datasets.
  • Delivered presentations at 18 industry conferences.
  • Achieved full alignment with method standards.
  • Collaborative leader with expertise in FDA/EMA regulations.

Accomplishments

  • Championed Good Clinical Data Management practice training for 10 staff members, increasing compliance rates by 75%.
  • Developed and optimized 14 real-time ad-hoc reports for key stakeholders, improving decision-making efficiency across multiple studies.
  • Instituted a comprehensive data quality control plan that improved trial accuracy and reliability for 13 global studies.
  • Devised new discrepancy management procedures, contributing to a 72% reduction in data quality issues across 14 ongoing studies.
  • Created automated data validation processes, reducing data entry errors by 54% and saving standard per week in manual review time.
  • Developed reporting mechanisms using Adobe Creative Suite that provided real-time insights into study progress, helping stakeholders address discrepancies faster.
  • Led the effort to optimize clinical trial data flows by introducing automated routines, reducing manual data cleaning time by 56%.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Documented and resolved program which led to category.
  • Collaborated with cross-functional teams (clinical, programming, biostatistics) to achieve system, ensuring datasets were locked on time.

Affiliations

  • Electronic Health Record (EHR) Data Governance Group
  • Society for Clinical Data Management (SCDM)
  • Sigma Xi, The Scientific Research Honor Society
  • Society for Clinical Research Sites (SCRS)
  • American Medical Informatics Association
  • International Biometric Society (IBS)
  • Clinical Trial Data Transparency Interest Group
  • Certified Clinical Data Manager (CCDM) Certification
  • Certification in Good Clinical Data Management Practices (CDMP)
  • International Association of Administrative Professionals

Certifications

  • Project Management Professional (PMP) – Project Management Institute (PMI)
  • Certified Clinical Data Manager (CCDM) - Society for Clinical Data Management (SCDM)
  • Certified Clinical Research Project Manager - Beacon Labs
  • Certified Clinical Data Management Specialist (CCDMS) - DIA Fellowship
  • Real World Evidence and Data Management Certification - Beacon Labs
  • Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals (ACRP)
  • Certified Business Analysis Professional (CBAP)
  • CompTIA A+ Technician
  • Certified Public Accountant (CPA)
  • Certified in Electronic Data Capture (EDC) Systems - Workday

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