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Skills

  • Raw material testing
  • Database management
  • Clinical operations process improvement
  • Supervision
  • Organization
  • Bioinformatics collaboration in trial design
  • Medical writing for regulatory documents
  • GCP (Good Clinical Practice) standards
  • Patient recruitment strategy development
  • First-round FDA approval achievement

Work Experiences

  • Chaired weekly cross-functional meetings to align project milestones with regulatory requirements, achieving method within category for metric.
  • Had an excellent attendance record and was always on time for work.
  • Authored clinical study protocols.
  • Solved initiative issues, improved operations, and provided excellent customer service.
  • Transported Workday to one year customer locations.
  • Collaborated with a pathologist to identify anomalies and narrow down possible diagnoses.
  • Achieved a 20% increase in study power for pivotal trials.
  • Collaborated with clinical, regulatory, and data science teams.
  • Achieved expedited approval.
  • Coordinated with regulatory authorities to draft non-clinical sections for accelerated product submission, resulting in a successful breakthrough therapy designation in 2016.

Summaries

  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Achieved 19% improvement in timelines.
  • Conducted comprehensive team training.
  • Strengths in performance reporting and risk assessment backed up by Miscellaneous training.
  • Costs were consistently reduced while profits were increased.
  • Within Miscellaneous, senior Senior Clinical Scientist and outstanding performer in workflow optimization and vendor management.
  • Achieved first-round approval for system.
  • Achieved regulatory success.
  • Dedicated to learning, growing, and succeeding in Miscellaneous.
  • Achieved 32% in protocol deviation reductions.

Accomplishments

  • Led the design and implementation of risk-based monitoring strategies, cutting monitoring costs by 60% and improving data quality oversight.
  • Formulated patient stratification models for precision medicine trials, increasing treatment efficacy measurement accuracy by 26%.
  • Reduced protocol deviations by 73% in oncology trial studies through process training, comprehensive SOP updates, and team-wide meetings.
  • Executed comprehensive training initiatives for clinical staff, realizing a 77% improvement in protocol comprehension and adherence.
  • Secured ITIL for human subject protection protocols, which enhanced compliance and safeguarded patient welfare across 11 clinical sites.
  • Increased efficiency of patient enrollment strategies, resulting in 82% faster recruitment across 18 trial sites with reduced dropout rates.
  • Designed and implemented an adverse event tracking system, reducing reporting delays by 78% and improving study integrity.
  • Supervised the management of post-market surveillance data for Jira, providing critical patient outcome metrics to safety boards and regulatory bodies.
  • Authored and revised clinical study protocols that accelerated submission approval timelines by 75% due to increased data accuracy and compliance with guidelines.
  • Authored and submitted 9 abstracts and manuscripts to major scientific conferences, increasing visibility of the clinical research program.

Affiliations

  • Society for Clinical Trials (SCT)
  • European Society for Translational Medicine (EUSTM)
  • Biomarkers Consortium Steering Committees
  • American College of Epidemiology
  • Society of Women Engineers
  • Freemason
  • Society of Toxicology (SOT)
  • American Society of Clinical Oncology (ASCO)
  • Association of Clinical Research Professionals (ACRP)
  • American Pharmacists Association (APhA) Special Interest Group on Clinical Research

Certifications

  • Certified Business Analysis Professional (CBAP)
  • CompTIA Security+
  • Google Certified Professional Cloud Architect
  • ICH-GCP E6(R2) Certification – 2024 – Lakeside Partners
  • Advanced Statistical Analysis Techniques for Clinical Data – Northwind
  • First Aid/CPR Certified
  • Advanced Biostatistics Certification - Ironclad Systems
  • Certified Biomarker Analysis Professional (CBAP) – Vantage
  • Data Monitoring Committee (DMC) Certification – Ironclad Systems
  • Salesforce

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