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Skills

  • Data oversight
  • MS Office
  • Team management
  • Data integrity monitoring and control
  • Clinical study report delivery
  • Customer service
  • First Aid/CPR
  • Cross-functional team leadership
  • Adverse event reporting optimization
  • Operational improvement

Work Experiences

  • Collaborated with clinical scientists to design custom database solutions for program, improving accuracy in patient-reported outcomes by 69%.
  • Continuously improved data reconciliation processes.
  • Acted as the primary data management liaison to sponsors.
  • Saved $13 by putting in place cost-cutting measures that addressed long-standing issues.
  • Coordinated Study Data Tabulation Model maps with programming.
  • Achieved 12% data accuracy.
  • Analyzed and managed data for a large-scale epidemiological study, influencing key regulatory decision-making processes.
  • Acted as the primary data management liaison to sponsors, facilitating seamless communication to ensure all deliverables met project milestones.
  • Contributed to risk-based monitoring strategies, accelerating data review timelines by 40% across 15 country sites.
  • Authored data management sections for 15 regulatory submissions.

Summaries

  • Cut error rates by 55%.
  • Achieved 66% fewer queries.
  • Within Miscellaneous, senior Senior Clinical Data Manager and outstanding performer in strategic planning and process improvement.
  • Collaborated with IT departments to integrate Adobe Creative Suite.
  • Dedicated to improving clinical data management, organization, and reporting through superior research, investigation, and project management skills.
  • Boosted overall trial efficiency.
  • Hardworking and pragmatic, with a methodical approach and strong attention to detail.
  • Collaborated with trial sponsors.
  • Achieved zero critical findings.
  • Dedicated in spearheading retrospective data analysis, ensuring the comprehensive delivery of clinical study findings within two years.

Accomplishments

  • Successfully managed 9 clinical studies in process, ensuring full regulatory compliance and meeting all deliverables within the specified three years.
  • Developed and executed a comprehensive data management training program for a global team of 6 data managers, resulting in increased adherence to SOPs and industry standards.
  • Collaborated with biostatistics team to define and standardize data cleaning procedures, preparing final datasets in compliance with CDISC standards ahead of regulatory submission.
  • Collaborated with team of 17 in the development of category.
  • Created customized data reports from initiative, providing key stakeholders with actionable insights and reducing decision-making lag by 85%
  • Successfully utilized QuickBooks for data cleaning and reconciliation, driving a 22% reduction in data entry-related delays.
  • Oversaw the data migration process for legacy system updates, ensuring seamless integration and a 53% increase in system efficiency.
  • Collaborated closely with the medical writing and programming teams to finalize clinical study reports, submitting 16 reports to regulatory bodies 6 months ahead of schedule.
  • Led efforts to optimize clinical trial data workflow automation using Salesforce, resulting in a 72% cut in manual data entry and review time.
  • Developed and implemented a comprehensive data validation protocol, reducing data discrepancies across 2 clinical trials by 79%.

Affiliations

  • Clinical Data Interchange Standards Consortium (CDISC)
  • Society for Immunotherapy of Cancer (SITC)
  • Clinical Trials Transformation Initiative (CTTI)
  • Biomedical Science Network (BioMedNet)
  • Drug Information Association (DIA)
  • American Society of Safety Professionals
  • Pharmaceutical Users Software Exchange (PhUSE)
  • Jaycees
  • American Society for Clinical Pathology (ASCP)
  • International Council of Nurses

Certifications

  • Associate of Clinical Research (ACR) by The Association of Clinical Research Professionals (ACRP)
  • Clinical Data Management Certification by PERI (Pharmaceutical Education & Research Institute)
  • Certified Business Analysis Professional (CBAP)
  • Certified Clinical Research Coordinator (CCRC) by ACRP
  • Regulatory Affairs Certification (RAC) by Regulatory Affairs Professionals Society (RAPS)
  • First Aid/CPR Certified
  • Advanced Clinical Trials and Data Management Certificate by The Institute for Continuing Healthcare Education
  • Certified EDC (Electronic Data Capture) Specialist by Vantage
  • Medical Device Development Fundamentals Certificate by Center for Professional Innovation & Education
  • American Society of Clinical Oncology (ASCO) Molecular Biology in Clinical Practice Certification

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