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Skills

  • Clinical operations process optimization
  • Clinical trial reporting
  • Customer service
  • Budgets
  • Test script writing
  • Clinical trial milestone tracking
  • Organization
  • Data oversight
  • Data discrepancy rate reduction
  • Electronic Data Capture (EDC) system implementation

Work Experiences

  • Conducted contract negotiations for labs and IVR/IWR systems.
  • Transported SAP to two years customer locations.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.
  • Assessed the clinical quality management plan.
  • Saved $2 by putting in place cost-cutting measures that addressed long-standing issues.
  • Pushed for operational changes that resulted in cost savings and higher profit margins.
  • Chaired cross-functional operational review meetings, driving actionable insights that improved patient retention rates by 83%.
  • Decreased approval turnaround time by 44% %.
  • Avoided delays caused by unforeseen site shutdowns.
  • Achieved metric for consistent audit readiness.

Summaries

  • Adept at cost reduction.
  • Adept at cost reduction, having saved 2 annually by optimizing clinical trial workflows and negotiating favorable vendor contracts.
  • Clinical Operations Manager with a proven track record.
  • Accomplished in trial site onboarding.
  • Hardworking and pragmatic, with a methodical approach and strong attention to detail.
  • Costs were consistently reduced while profits were increased.
  • Clinical Operations Manager with an established track record of developing project-specific training materials, ensuring 35% compliance rates for clinical staff.
  • Ready to contribute 6 years of experience to a fast-paced position with room for growth.
  • Achieved success across multiple regions.
  • Delivered projects on time and within budget.

Accomplishments

  • Secured partnerships with key vendors through detailed contract negotiations, reducing trial service costs by 16%, saving approximately $13 annually.
  • Led the site initiation visit (SIV) process for 5 sites, ensuring that all regulatory and operational guidelines were met within first review.
  • Presented operational performance metrics to senior management, resulting in process impact on strategic planning for future trials.
  • Managed relationships with contract research organizations (CROs) and third-party vendors, delivering trials on-budget and within expected timelines.
  • Supervised a multidisciplinary team of 13, ensuring compliance with GCP and FDA regulations across all clinical trial sites.
  • Implemented a centralized site management plan that reduced site communication lag by 78% while maintaining data integrity.
  • Resolved product issue through consumer testing.
  • Ensured that all adverse events were reported within program, maintaining 20% compliance with international and local regulatory bodies.
  • Established cross-functional communication between clinical sites and stakeholders, achieving 33% on-time project delivery.
  • Executed clinical audits to ensure compliance with framework, resulting in no findings during a subsequent regulatory review.

Affiliations

  • International Council of Nurses
  • Association for Computing Machinery
  • Lions Club
  • Society for Clinical Research Sites (SCRS)
  • Society of Clinical Research Associates (SOCRA) - Certified Clinical Research Professional
  • International Conference on Harmonisation of Technical Requirements for Pharmaceuticals (ICH) Conference Member
  • International Society for Pharmacoeconomics and Outcomes Research (ISPOR)
  • Association for Strategic Planning Healthcare Special Interest Group
  • Jaycees
  • Association of Clinical Research Professionals (ACRP) - Certified Clinical Research Coordinator (CCRC)

Certifications

  • Trial Master File (TMF) Management Certification - Summit Group
  • Clinical Research and Regulatory Affairs Certification - Denver
  • Advanced Project Management in Clinical Research - Harbor & Co.
  • Healthcare Regulatory Law Certification - Meridian
  • Certified International Clinical Trials Manager - Lakeside Partners
  • Risk Management in Clinical Research Certification - Summit Group
  • Certified Business Analysis Professional (CBAP)
  • Certified Professional in Healthcare Quality (CPHQ) - process
  • Certified Public Accountant
  • Clinical Data Management (CDM) Certification - Asana

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