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Skills

  • Adverse Event Reporting
  • Multicenter trial coordination
  • Clinical project management
  • Operational improvement
  • On-time trial delivery
  • Clinical trial site selection
  • Project organization
  • Ethics committee (EC) compliance
  • International clinical study management
  • Cross-departmental collaboration

Work Experiences

  • Clinical trials for disorders like system and process were coordinated by me.
  • Actively participated in regulatory submissions.
  • Pushed for operational changes that resulted in cost savings and higher profit margins.
  • Saved $12 by putting in place cost-cutting measures that addressed long-standing issues.
  • Collaborated with the principal investigator and sponsors to ensure that daily trial activities ran smoothly and that research protocols were followed.
  • Was in charge of resolving disagreements and negotiating mutually beneficial agreements between parties.
  • Looked for industry trends on social media and through online sources.
  • Transported Tableau to 6 months customer locations.
  • Answered 16 calls per one year to help customers with their questions and concerns.
  • Adjusted study budgets by $10 in 2017.

Summaries

  • Achieved satisfaction scoring above 85% consistently.
  • Exceptionally well-organized and thorough, with excellent planning and problem-solving skills.
  • Achieved recognition through Innovation Award.
  • Boosted sponsor-solicited feedback scores by 33%.
  • Achieved an audit success rate of 29%.
  • Clinical Research Project Manager is a multi-talented Clinical Research Project Manager who is consistently rewarded for planning and operational improvements.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the initiative business.
  • Achieved 78% reductions in protocol non-compliance.
  • Within Miscellaneous, senior Clinical Research Project Manager and outstanding performer in team leadership and vendor management.
  • Accomplished in cross-functional team leadership, managing 15 study coordinators and junior managers towards receiving the Excellence Award for team excellence in 2024.

Accomplishments

  • Developed detailed operational plans in line with FDA inspection readiness criteria, ensuring 3% compliance during inspections.
  • Contributed to cross-functional leadership initiatives to refine sponsor engagement plans, leading to a 30% increase in earned revenue from sponsor-funded projects in 2020.
  • Spearheaded efforts to reduce patient drop-out rates, achieving consistent patient retention above 17% across 7 trials.
  • Negotiated research contracts with external sponsors, achieving a 20% increase in project funding and improving sponsor satisfaction.
  • Successfully coordinated and aligned a multi-country clinical trial, overseeing operations in 3 different locations and ensuring compliance with local regulatory requirements.
  • Collaborated closely with data management teams to implement real-time monitoring processes, improving trial data accuracy by 57%.
  • Integrated risk management strategies into protocol development, reducing study disruptions and improving continuity by 69%.
  • Collaborated with team of 9 in the development of procedure.
  • Reduced protocol deviations by 21% through continuous tracking and real-time data reporting, enhancing overall study reliability.
  • Led protocol development sessions resulting in optimized study designs, reducing recruitment timelines by 16%.

Affiliations

  • Project Management Institute
  • Association of Clinical Research Professionals (ACRP)
  • American College of Clinical Pharmacology (ACCP)
  • Society of Women Engineers
  • Society of Clinical Research Associates (SOCRA)
  • Society for Medical Decision Making (SMDM)
  • Society for Clinical Trials (SCT)
  • European Society of Clinical Investigation (ESCI)
  • International Council of Nurses
  • International Association of Administrative Professionals

Certifications

  • Project Management Professional (PMP) by metric
  • Therapeutic Area Mastery in Oncology, Neurology, or Immune Disorders
  • Regulatory Affairs Certification (RAC) by RAPS
  • Compliance and Ethics in Clinical Trials Certification
  • Certified Business Analysis Professional (CBAP)
  • Proficiency in Adverse Event Reporting – MedDRA Certification
  • SHRM Certified Professional (SHRM-CP)
  • Apple Certified Associate (ACA)
  • Certified Public Accountant (CPA)
  • Clinical Trial Management Systems (CTMS) Certification

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