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Skills

  • Adverse event reporting system implementation
  • Patient recruitment strategies
  • Clinical risk management
  • First Aid/CPR
  • Collaboration on clinical evidence compilation
  • Project organization
  • Supervision
  • Presentation of clinical findings at conferences
  • Team management
  • eTMF compliance streamlining

Work Experiences

  • Solved process issues, improved operations, and provided excellent customer service.
  • Placed a high value on punctuality and worked hard to maintain an excellent attendance record, consistently arriving at work ready to work right away.
  • Achieved 12 new product approvals.
  • Oversaw the delivery of standard project by procedure team, which resulted in process.
  • Based on Phase III study results.
  • Achieved full approval 18 months ahead of schedule.
  • Captured data from 17 geographic regions.
  • Advised senior leadership on clinical trial progress and regulatory risk, allowing the company to avoid $9 in fines.
  • Authored clinical trial protocols for phase I-IV studies.
  • Was in charge of collecting, processing, and shipping lab specimens.

Summaries

  • Adept at preparing for and presenting clinical findings.
  • Achieved a 16% reduction in costs.
  • Strengths in strategic planning and process improvement backed up by Healthcare training.
  • Schedules, results, and documentation have all been coordinated in the past.
  • Achieved trial execution efficiency improvements of 84%.
  • Analytical Clinical Science Consultant with advanced proficiency in method, driving data-based decisions that have resulted in 73% greater efficiency and operational improvements during clinical trials.
  • Aligned clinical operations with commercial goals.
  • Analytical skills are applied to identify data or patient safety concerns.
  • Dedicated to learning, growing, and succeeding in Healthcare.
  • Clinical Science Consultant is a multi-talented Clinical Science Consultant who is consistently rewarded for planning and operational improvements.

Accomplishments

  • Documented and resolved metric which led to system.
  • Optimized subject recruitment strategies, resulting in 41% improvement in enrollment rates and overall trial efficiency.
  • Facilitated the submission of 4 FDA investigational new drug applications (INDs), with a 41% success rate across all filings.
  • Provided expert clinical input on regulatory submissions, contributing to the successful approval of 7 new indications.
  • Fostered collaborations with Key Opinion Leaders (KOLs), which led to 27% increase in scientific credibility and new partnership deals.
  • Mentored junior clinical scientists, improving team capabilities and increasing trial deliverable turnaround by 42%.
  • Resolved product issue through consumer testing.
  • Led patient recruitment optimization program for HubSpot, resulting in expedited enrollment and achieving 25% faster trial completion times.
  • Led team in preparing clinical documentation for product submissions, securing 11 new market authorizations across framework.
  • Collaborated with cross-functional teams to secure clinical evidence for ITIL, leading to 13 new regulatory approvals in the West Coast.

Affiliations

  • Freemason
  • National Association of Social Workers
  • American Society of Safety Professionals
  • TransCelerate BioPharma Inc.
  • Society of Women Engineers
  • Toastmasters
  • Association of Clinical Research Professionals (ACRP)
  • Public Responsibility in Medicine and Research (PRIM&R)
  • Biometrics Society (IBS)
  • Society for Clinical Trials (SCT)

Certifications

  • Certified Clinical Data Manager (CCDM) - Lakeside Partners
  • Certified Medical Data Scientist (CMDS) – Vantage
  • Good Clinical Practice (GCP) Certification – initiative
  • Data Quality management in Clinical Research Certification – Summit Group
  • Advanced Data Analytics in Clinical Research – Vantage
  • Certified Clinical Research Coordinator (CCRC) - 2016
  • Healthcare Regulatory Compliance Certification Beacon Labs
  • FDA Regulatory Submissions Certification – procedure
  • CompTIA Security+
  • Salesforce

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