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Skills

  • Design of data capture forms
  • Budgets
  • Clinical study data collection and aggregation
  • Communications
  • Data discrepancy resolution
  • Operational improvement
  • Business intelligence (BI) tools (e.g., Tableau, Power BI)
  • Clinical site data consistency monitoring
  • Discrepancy management
  • Biostatistics collaboration

Work Experiences

  • Contributed to passing framework audits.
  • Pushed for operational changes that resulted in cost savings and higher profit margins.
  • Automated discrepancy management processes using Adobe Creative Suite.
  • Customized database configurations for 4-site clinical trials, optimizing workload distribution and lowering the error rate by 47%.
  • Achieved regulatory approval in one year.
  • Contributed to the successful submission of findings.
  • Achieved approvals without major findings.
  • Collaborated with principal investigators.
  • Created a data tracking and tracing protocol tailored to Adobe Creative Suite, leading to regulatory approval in 6 months and securing 3 in funding.
  • Customized database configurations for 18-site clinical trials.

Summaries

  • Adept at leveraging Jira to automate clinical workflows.
  • 16 years of experience in clinical trial data management.
  • Clinical Data Analyst focused on enhancing data quality and integrity.
  • Achieved recognition in 2019.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Achieved a 23% improvement in regulatory compliance across all trials.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Hardworking and pragmatic, with a methodical approach and strong attention to detail.
  • Within Miscellaneous, senior Clinical Data Analyst and outstanding performer in budget management and cross-functional collaboration.
  • Automated data discrepancy management.

Accomplishments

  • Developed real-time data validation checks within eCRFs, cutting down on data entry errors by 79% in the first 17 months of implementation.
  • Streamlined the process for data discrepancy management using ServiceNow, reducing data query turnaround time by 28%.
  • Led the preparation of clinical data for procedure submissions, ensuring all documents met program requirements ahead of deadlines.
  • Contributed to the success of Miscellaneous by improving patient enrollment tracking using an interactive dashboard, which increased enrollment rates by 45%.
  • Designed and implemented customized eCRFs (Electronic Case Report Forms) in SAP, streamlining data capture processes and reducing data entry time by 27%.
  • Helped publish 17 peer-reviewed articles by supporting thorough data analysis and ensuring compliance with submission guidelines.
  • Collaborated with the medical writing team to simplify clinical data summaries, contributing to faster reporting cycles and enhanced regulatory readability.
  • Established procedures for data audits that reduced discrepancies in clinical trial data by 58%, ensuring compliance with metric.
  • Oversaw the archiving and documentation of study data across 15 trials, ensuring compliance with Good Clinical Practice (GCP) regulations.
  • Influenced protocol changes by highlighting trends discovered across 3 clinical studies, saving 9 by improving trial safety measures.

Affiliations

  • Participation in Pharmacoepidemiology and Drug Safety analytics working group
  • Certified in handling and protecting clinical data through the International Organization for Standardization (ISO) 27001 certification program
  • Affiliated with the Association for Clinical Data Management Professionals (ACDM)
  • Member of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
  • Attended Clinical Data Science meetups powered by OpenClinica
  • Member of the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI)
  • American Medical Informatics Association
  • Participant in coding and automation workshops hosted by CDISC (Clinical Data Interchange Standards Consortium)
  • Partnered with academic institutions for internship placements via the Clinical Data Scientist Internship Consortium
  • Alumni of the Clinical Research Information Exchange Annual Conference

Certifications

  • CompTIA Security+
  • Certified Professional in Healthcare Information and Management Systems (CPHIMS) – HIMSS
  • Certified Investigator Site Personnel (CISP) Certification
  • SHRM Senior Certified Professional (SHRM-SCP)
  • Certified Business Analysis Professional (CBAP)
  • Google Data Analytics Professional Certificate
  • ServSafe
  • AWS Certified Machine Learning – Specialty
  • Machine Learning Specialization by Stanford University (Asana)
  • Advanced SAS Certification by system

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