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Skills

  • Patient retention strategies
  • Bottleneck resolution in trials
  • Project organization
  • Data-driven decision making
  • MS Office
  • FDA regulatory compliance
  • Trial management
  • Informed consent
  • Problem resolution
  • Operational improvement

Work Experiences

  • Conducted regular risk assessments for ongoing clinical trials, mitigating potential delays impacting 15-million-dollar assets while preserving high-quality standards.
  • Clinical trials for disorders like system and method were coordinated by me.
  • Consistently delivered results within 49% of fiscal targets.
  • Ensured that all protocols pertaining to patient care and clinical trial operations were followed.
  • Completed process within 18 months.
  • Looked through patient records, databases, and physician referrals to find potential research participants.
  • Collaborated with cross-functional teams.
  • Achieved a 54% margin increase.
  • Collaborated with Institutional Review Boards (IRBs).
  • Achieved 15% faster site selection.

Summaries

  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Applied cutting-edge technology in clinical trial management.
  • Clear understanding of quality assurance and vendor management as well as quality assurance training.
  • Excellent track record of resolving issues, increasing customer satisfaction, and driving overall operational improvements.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • As a Senior Clinical Trial Operations Manager.
  • Adept at managing complex clinical trial portfolios.
  • Bridging operational and clinical roles to streamline processes, reduce timelines by 30%, and ensure high levels of team collaboration across trials.
  • Clinical Research Coordinator with a strong understanding of study protocols, SOPs, and general trial oversight.
  • A senior professional with an expertise in Clinical Trial Management Systems (CTMS) integration, improving data harmonization and streamlining operations across 14 global programs.

Accomplishments

  • Negotiated and secured contracts with external vendors, resulting in a 68% reduction in trial material costs while maintaining high-quality standards.
  • Documented and resolved procedure which led to method.
  • Spearheaded the data integrity audit across 12 global sites, leading to zero critical findings and expedited regulatory approval.
  • Directed Phase 5 clinical trials with a focus on quality and compliance, achieving rapid site activation in 3 days across 9 regions.
  • Reduced operational costs by 77% through contractual renegotiation with CROs while maintaining the highest quality service delivery.
  • Secured funding for a first-in-class Phase 18 trial, justifying budget needs that led to successful study initiation and zero overspend.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Resolved product issue through consumer testing.
  • Designed and initiated database lock processes 18% faster by improving cross-functional team communication and data management tools.
  • Led cross-functional teams working across 7 sites, realizing a 74% reduction in deviations and ensuring audit readiness.

Affiliations

  • Project Management Institute
  • American Society for Clinical Pharmacology and Therapeutics (ASCPT)
  • Jaycees
  • American College of Clinical Pharmacology (ACCP)
  • International Society for Clinical Pharmacology and Therapeutics (ISCPT)
  • Association for Computing Machinery
  • Regulatory Affairs Professionals Society (RAPS)
  • International Clinical Research Organization (ICRO)
  • World Association of Medical Editors (WAME) – Clinical Trials Oversight
  • Biomedical Research Alliance of New York (BRANY)

Certifications

  • Human Subjects Research (HSR) - Collaborative Institutional Training Initiative (CITI)
  • Clinical Data Manager Certification Program (CDMCP) - Society for Clinical Data Management (SCDM)
  • Certified Principal Investigator (CPI) - ACRP
  • Lean Six Sigma Green Belt Certification Meridian
  • SHRM Certified Professional (SHRM-CP)
  • Advanced Good Clinical Practices (GCP) - Summit Group
  • Certified in the Fundamentals of Human Subject Protection - Summit Group
  • Good Clinical Practice (GCP) Certification - Northwind
  • Certified Clinical Trial Investigator (CCTI) - ACRP
  • Clinical Trial Management System (CTMS) Certification - SAP

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