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Skills

  • Database finalization
  • System equipment
  • SOP compliance
  • Data-driven insights generation
  • MS Office
  • Clinical trial data query resolution
  • Process improvement
  • Database management for clinical trials
  • Clinical protocol adherence
  • Advanced data reporting

Work Experiences

  • Created complex reports for study outcomes.
  • Collaborated with study management teams.
  • Contributed to protocol development.
  • Collaborated with system customers to determine their needs and deliver process service.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Answered 4 calls per 18 months to help customers with their questions and concerns.
  • Coordinated with international investigators.
  • Transported Microsoft Excel to one year customer locations.
  • Analyzed and interpreted complex clinical data sets to provide actionable insights that contributed to the approval of 8 product applications.
  • Coordinated Study Data Tabulation Model maps with programming.

Summaries

  • Results-oriented, precise, and systematic, with an aptitude for quick learning and collaboration.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Achieved a 51% reduction in clinical data acquisition time.
  • Contributed to the flawless execution of 5 clinical trials.
  • Accelerated EMA approvals for Tableau.
  • Advanced skills in optimizing ETL workflows through ServiceNow, resulting in a 15% reduction in clinical data acquisition time.
  • Collaborative and efficient, known for improving project timelines by 46% through strong partnerships with biostatisticians and clinical researchers.
  • Hardworking and pragmatic, with a methodical approach and strong attention to detail.
  • Adept at identifying discrepancies.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the method business.

Accomplishments

  • Facilitated communication with cross-functional teams to ensure reporting mechanisms adhered to clinical trial timelines, reducing feedback delays by 64%.
  • Participated in cross-functional audit teams, identifying and rectifying 3 compliance issues during system, ensuring successful adherence to regulatory standards.
  • Collaborated with cross-functional teams to implement a new data quality dashboard that decreased report generation times by 4 hours.
  • Documented and resolved program which led to category.
  • Expedited resolution of database query tickets from stakeholders, reducing average response time to less than two years.
  • Developed a comprehensive data discrepancy resolution framework, achieving a 66% reduction in patient data discrepancies after its application.
  • Collaborated with clinical investigators to improve the design of data collection forms, reducing redundant fields and cutting entry time by 61%.
  • Achieved a 30% reduction in data loss incidents by implementing new patient information backup protocols.
  • Led quality assurance testing during clinical system upgrades, eliminating 3 critical errors prior to the system's deployment.
  • Developed SQL-based solutions to increase the speed of data validation, improving overall process efficiency by 44%.

Affiliations

  • Toastmasters
  • Good Clinical Practice (GCP) Certification
  • American Society of Safety Professionals
  • American Statistical Association (ASA)
  • eClinical Forum Member
  • American Public Health Association (APHA)
  • National Association of Social Workers
  • American Medical Informatics Association
  • Certification in Statistical Computing with SAP
  • Global Health Data Exchange Contributor (GHDx)

Certifications

  • Certified Clinical Research Coordinator (CCRC) procedure
  • Lean Six Sigma Green Belt Certification – Beacon Labs
  • Pharmaceutical Good Manufacturing Practice (GMP) Certification - Harbor & Co.
  • ISO 14155 for Medical Device Clinical Investigations Certification
  • Certified Clinical Data Manager (CCDM) - Society for Clinical Data Management (SCDM)
  • Clinical Data Acquisition System Specialist (CDAS) Certification
  • ICH GCP - Good Clinical Practice Certification - International Council for Harmonisation
  • Good Clinical Practice (GCP) Certification - Transcelerate Biopharma
  • CompTIA Network+
  • SHRM Senior Certified Professional (SHRM-SCP)

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