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Skills

  • MS Office
  • Clinical database design and optimization
  • Data entry interface design
  • Process improvement
  • Metric equipment
  • Relationship development
  • Problem resolution
  • Clinical trial information management
  • Cross-functional team collaboration
  • Clinical trial phase oversight

Work Experiences

  • Developed predictive models.
  • Designed clinical data specifications for SAP.
  • Conducted comprehensive data audits.
  • Achieved 51% completion rate.
  • Collaborated with biostatisticians.
  • Awarded Employee of the Year for excellence in data management.
  • Achieved a 28% decrease in missing values.
  • Achieved 42% faster database lock.
  • Oversaw the delivery of framework project by metric team, which resulted in framework.
  • Coordinated real-time data collection for Adobe Creative Suite.

Summaries

  • Dedicated Clinical Data Specialist.
  • Achieved accurate reporting on tight deadlines.
  • Conducted clinical data analysis.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Created standardized CRF completion guidelines.
  • Categorized adverse events more precisely.
  • Clinical Data Specialist with extensive experience in developing and maintaining secure, accurate, and efficient data collection systems.
  • Hardworking and pragmatic, with a methodical approach and strong attention to detail.
  • Applied analysis across multiple clinical trials.
  • Achieved 79% increase in data accuracy.

Accomplishments

  • Configured EDC systems to ensure compliance with SDTM standards, improving data readiness for future regulatory reviews by 85%.
  • Orchestrated the deployment of a new EDC platform, leading to a 60% increase in speed of data collection across 17 trial sites.
  • Liaised with biostatisticians to ensure high-quality data sets for complex statistical analysis, leading to more reliable clinical trial results.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Coordinated data lifecycle management protocols that ensured data retention and integrity for an FDA audit, leading to zero major findings.
  • Led the quality control check of data entry from 7 research centers, identifying and correcting 2 critical errors pre-DB lock.
  • Ensured adherence to GCP and ICH guidelines, which resulted in smooth FDA audit with zero critical findings.
  • Resolved product issue through consumer testing.
  • Created SOPs for clinical data management processes, resulting in a 58% increase in data accuracy and consistency.
  • Sync'd datasets with clinical team members to produce critical interim reports, expediting conversations with the method by 77%.

Affiliations

  • Toastmasters
  • Participant in the Drug Information Association (DIA)
  • Professional Association for SQL Certified Individuals
  • Attendee at the American Society for Bioinformatics
  • American Medical Informatics Association
  • Reviewer for Journal of Clinical Data Management
  • Involved in Observational Health Data Sciences and Informatics (OHDSI) collaborative
  • Part of the International Association for Statistical Computing (IASC)
  • Certified Professional in Electronic Data Capture (CPEDC)
  • Society of Clinical Research Associates (SOCRA) - Lean

Certifications

  • Certified Data Management Professional (CDMP) – Meridian
  • CompTIA Security+
  • Clinical Data Management (CDM) Certification - Meridian
  • Certified Data Privacy Solutions Engineer (CDPSE) - Ironclad Systems
  • Data Management & Analytics (DMA) for Clinical Trials Certification - Beacon Labs
  • CompTIA A+ Technician
  • Salesforce
  • Certified Public Accountant (CPA)
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Project Management Professional (PMP) - Northwind

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