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Skills

  • First Aid/CPR
  • Cross-functional team collaboration
  • Data entry error reduction strategies
  • SOP compliance
  • Budgets
  • Data reconciliation between systems (EDC & Safety)
  • EDC system training for research staff
  • Inter-process data flow management
  • Operational improvement
  • Clinical research training

Work Experiences

  • Collaborated with programming teams.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Achieved continuous data integrity across platforms.
  • Assisted in database migration processes for Salesforce, maintaining data integrity while reducing migration downtime by 27%.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Analyzed discrepancies in clinical database entries.
  • Collaborated with programming teams to develop automated data transfer procedures, decreasing manual intervention by 50%.
  • Collaborated with product.
  • Addressed discrepancy reporting within 6 months.
  • Solved framework issues, improved operations, and provided excellent customer service.

Summaries

  • Achieved process efficiencies.
  • Collaborated across teams.
  • Results-oriented, precise, and systematic, with an aptitude for quick learning and collaboration.
  • Clinical Data Coordinator with demonstrated expertise in managing adverse event tracking and reporting, decreasing reporting timelines by 53% and ensuring compliance with global standards.
  • Contributed to interim analyses.
  • Contributed to improved data accuracy by 52%.
  • Adept at resolving clinical data discrepancies through cross-team collaboration, achieving framework within one year and contributing to the success of ongoing trials.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Collaboration in biostatistics.
  • Aligned plans with regulatory standards.

Accomplishments

  • Created and maintained clinical study data dictionaries, ensuring consistent data formatting and reducing rework in 17 trials.
  • Coordinated timely database lock deliverables for 9 sponsor-initiated clinical trials, resulting in 35% on-time completions.
  • Trained 17 junior data analysts on clinical trial management systems (e.g. Medidata, Oracle Clinical) leading to a 65% increase in team efficiency.
  • Led the validation and verification process of clinical trial datasets, ensuring all regulatory submissions were on time and approved without discrepancies.
  • Reduced interim database update times by 74% through the implementation of system-level automation protocols.
  • Enhanced query management dashboards for medical monitors, improving decision-making turnaround by 60% hours in ongoing studies.
  • Managed the setup of 2 EDC platforms for multiple clinical studies, ensuring all data management activities adhered to GCP guidelines.
  • Developed a new data integration workflow, merging data from multiple EDC systems into a consolidated database, cutting down processing time by 37% hours.
  • Supervised the entry and cleaning of clinical data from multiple study sites, ensuring datasets were ready for statistical analysis within procedure.
  • Collaborated with engineering and external teams to ensure clinical databases aligned with regulatory requirements (ICH/GCP), contributing to on-time submission for 15 trials.

Affiliations

  • Drug Information Association (DIA)
  • Toastmasters
  • Rotary International
  • Health Information Management Systems Society (HIMSS)
  • American Association for Cancer Research (AACR)
  • International Association of Privacy Professionals (IAPP)
  • Society for Regulatory Affairs Professionals (SRAP)
  • National Association of Social Workers
  • Association for Supply Chain Management (APICS)
  • Healthcare Data & Analytics Association (HDAA)

Certifications

  • Society for Clinical Data Management (SCDM) Certified Blue Belt in Clinical Data Management - 2020
  • Certified Electronic Health Records Specialist (CEHRS) - 2022
  • CompTIA A+ Technician
  • Advanced EDC and Data Integrity Certification SAP - 2019
  • Certified Expert in Clinical Trial Data Solutions - 2016
  • Google Certified Professional Cloud Architect
  • Certified Health Research Records Supervisor (CHRS) - 2019
  • Certified Healthcare Data Analyst (CHDA) 2017
  • Certified Medical Regulatory Affairs Data Coordinator - 2018
  • Certified Clinical Data Quality Manager - 2015

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