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Skills

  • Production tracking
  • SOP compliance
  • Data reconciliation
  • Data validation and cleaning
  • Supervision
  • Clinical data quality assurance
  • Clinical data reporting
  • Organization
  • Database Audit Trails
  • Clinical Software Tools - Asana

Work Experiences

  • Achieved timely issue resolution.
  • Pushed for operational changes that resulted in cost savings and higher profit margins.
  • Collaborated with cross-functional teams to streamline clinical data workflows, producing a 51% reduction in data entry errors.
  • Achieved 80% reduction in timeline overruns.
  • Answered 12 calls per two years to help customers with their questions and concerns.
  • Had an excellent attendance record and was always on time for work.
  • Collaborated with Microsoft Excel vendors to automate data transfer processes, speeding up trial close-out phases by 68%.
  • Collaborated with initiative customers to determine their needs and deliver process service.
  • Coordinated the medical coding data process.
  • Conducted comprehensive data reviews.

Summaries

  • Strong ties to system businesses.
  • Clinical Data Assistant with a sharp focus on regulatory submission support and adherence to clinical trial timelines. Managed 11 trial databases, ensuring prompt delivery of accurate datasets to sponsors.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Consistently achieved deadlines.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Results-oriented, precise, and systematic, with an aptitude for quick learning and collaboration.
  • Adept Clinical Data Assistant with a strong ability to streamline clinical data workflows. Successfully reduced error rates by 66% while maintaining precise control over regulatory and compliance requirements.
  • Adept at monitoring data quality for Salesforce trials.
  • Achieved 100% adherence to study deadlines.

Accomplishments

  • Coordinated data transfers with external vendors, ensuring timely submission of key trial data for regulatory approvals.
  • Optimized data reconciliation processes, cutting task completion times by 49% and improving data accuracy.
  • Reduced data discrepancies by 56% through careful monitoring and quality checks during multi-site clinical trial coordination.
  • Monitored data metrics and produced weekly reports, which helped the team detect and correct discrepancies before they escalated.
  • Collaborated closely with clinical teams to design and implement CRF (Case Report Form) templates, leading to reduced data inconsistencies across 4 clinical trials.
  • Supported clinical data collection and entry for 11 global trials, ensuring compliance with FDA and EMA regulations.
  • Managed database maintenance for 4 clinical trials, ensuring compliance with regulatory requirements and inspection readiness.
  • Collaborated with external CROs to ensure timely and accurate data transfer across 12 clinical studies, maintaining audit-readiness.
  • Implemented data validation checks within SAP that reduced data discrepancies by 80%, improving overall trial data quality.
  • Streamlined data collection procedures, which reduced trial setup times by 35% for 14 clinical studies.

Affiliations

  • Clinical Data International Professionals Network
  • International Council of Nurses
  • Jaycees
  • Society for Epidemiologic Research (SER)
  • Health Information Management Systems Society (HIMSS)
  • Member, Association for Computational Health Statistics
  • Clinical Data Interchange Standards Consortium (CDISC)
  • Project Management Institute
  • Certified Professional in Healthcare Information & Management Systems (CPHIMS)
  • Certified in HIPAA Privacy & Security through method

Certifications

  • Project Management Essentials Certification - Management and Strategy Institute 2022
  • SHRM Certified Professional (SHRM-CP)
  • Clinical Terminology for International and U.S. Students - Stanford Online 2018
  • Google Certified Professional Cloud Architect
  • SQL for Data Science Certification - Coursera 2017
  • Certified Biostatistics Professional (CBP) - Statistical Association 2022
  • Cisco Certified Internetwork Expert (CCIE)
  • CompTIA Security+
  • Advanced Clinical Coding (ACC) Certification - AAPC 2016
  • Good Clinical Practice (GCP) Certification - Transcelerate Biopharma Inc. 2021

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