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Skills

  • Data management training development
  • Test script writing
  • Clinical Data Interchange Standards Consortium (CDISC) compliance
  • Database lock process improvement
  • Discrepancy resolution for clinical trials
  • Communications
  • Clinical database migration
  • Documentation of data management policies
  • Data querying and reporting in Tableau
  • Project organization

Work Experiences

  • Collaborated closely with biostatistics, medical writing, and programming teams to deliver final clinical study reports three years ahead of schedule.
  • Analyzed data for a large-scale epidemiological study.
  • Collaborated with framework to customize clinical data management solutions that increased data-entry productivity by 58%.
  • Contributed to risk-based monitoring strategies, accelerating data review timelines by 40% across 15 country sites.
  • Had an excellent attendance record and was always on time for work.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Acted as the primary data management liaison to sponsors.
  • Achieved 53% faster identification of protocol deviations.
  • Collaborated with biostatistics, medical writing, and programming teams.
  • Acted as the primary data management liaison to sponsors, facilitating seamless communication to ensure all deliverables met project milestones.

Summaries

  • Within Miscellaneous, senior Senior Clinical Data Manager and outstanding performer in strategic planning and process improvement.
  • Accelerated timelines for high-quality data analysis.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Accomplished in automating data review processes.
  • Clear understanding of workflow optimization and performance reporting as well as strategic planning training.
  • Boosted overall trial efficiency.
  • Committed to ensuring data integrity through effective query management, having reduced the number of queries generated per study by 51%.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the system business.
  • Costs were consistently reduced while profits were increased.
  • Senior Clinical Data Manager with 2 years of successful strategic planning and client relations experience.

Accomplishments

  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Directed the implementation of category across 15 multinational clinical studies, ensuring system compatibility and improving data integrity.
  • Reduced query volume by 75% through proactive data discrepancy monitoring and improved data collection protocols in framework.
  • Oversaw the data migration process for legacy system updates, ensuring seamless integration and a 53% increase in system efficiency.
  • Executed cross-functional data management strategies with the programming and biostatistics departments, leading to a 46% increase in overall productivity.
  • 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.
  • Ensured regulatory compliance by collaborating with the QA department to audit and update existing data management SOPs, maintaining PMP standards across all active studies.
  • Successfully managed 9 clinical studies in process, ensuring full regulatory compliance and meeting all deliverables within the specified three years.
  • Coordinated with CROs and external vendors to ensure timely and compliant data transfers, accelerating study timelines by 58% compared to projected milestones.
  • Successfully designed and maintained databases for 16 clinical trials, leveraging system to enhance data collection efficiency and reporting accuracy.

Affiliations

  • Drug Information Association (DIA)
  • ISO/IEC standard of Data Management Taskforce
  • International Biometrics Society (IBS)
  • Healthcare Research and Quality (HRQ)
  • Biomedical Science Network (BioMedNet)
  • American Society for Clinical Pathology (ASCP)
  • Rotary International
  • International Council of Nurses
  • Freemason
  • International Association of Clinical Research Nurses (IACRN)

Certifications

  • Oracle Health Sciences Certified Implementation Specialist
  • Clinical Data Interchange Standards Consortium (CDISC) Certified Professional
  • SHRM Certified Professional (SHRM-CP)
  • Certified Associate in Project Management (CAPM) by PMI
  • Regulatory Affairs Certification (RAC) by Regulatory Affairs Professionals Society (RAPS)
  • Medical Device Development Fundamentals Certificate by Center for Professional Innovation & Education
  • Certified Public Accountant
  • Microsoft Certified Systems Engineer (MCSE)
  • Project Management Professional (PMP) by the Project Management Institute (PMI)
  • Project Management Professional (PMP)

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