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Skills

  • Drug inventory management
  • Compliance with ICH-GCP guidelines
  • Seasoned in medical clinical procedures
  • Occupancy strategies
  • Clinical trial site coordination
  • Budget forecasting and cost control
  • Wellness services
  • Clinical data analysis and reporting
  • Therapy programs
  • Clinical protocol development

Work Experiences

  • Authored standard operating procedures (SOPs) for clinical activities.
  • Authored and updated standard operating procedures (SOPs) for a range of clinical activities, resulting in a 58% decline in operational inconsistencies.
  • Achieved 65% higher retention rates.
  • Collaborated with IT to implement innovative e-CRF platforms, notably reducing data lock times by 8 weeks.
  • Collaborated with external advisory boards.
  • Compounding, mixing, packaging, and labeling procedures were all implemented by me.
  • Conducted comprehensive competitor analysis which led to the development of superior clinical strategies, improving trial enrollment by 25%.
  • Completed approvals 5 months ahead of schedule.
  • Achieved a 76% reduction in site visit frequency.
  • Achieved a 83% increase in clinical trial enrollment rates.

Summaries

  • Clinical Affairs Manager with 16 years of successful cross-functional collaboration and client relations experience.
  • Hope to help Lakeside Partners achieve even greater success by leveraging my personal skill set and proactive demeanor.
  • Aligned clinical objectives with corporate goals.
  • With more than 9 years of experience managing operations in patient-centered medical offices, this professional is highly skilled and enthusiastic.
  • Adept at incorporating patient-centric outreach initiatives.
  • Bringing a successful career history of more than 2 years to the table.
  • Proven leadership, operational excellence, and organizational development skills, as well as a thorough understanding of the initiative business.
  • Costs were consistently reduced while profits were increased.
  • Overall morale and productivity are boosted by experience in policy development and staff management procedures.
  • Accomplished in developing clinical strategies.

Accomplishments

  • Led cross-functional internal audit preparation for ServiceNow clinical trials, achieving full FDA compliance on the first attempt.
  • Presented protocol amendments to regulatory bodies, expediting approval by 9 months and positively impacting trial timelines.
  • Drove forward-thinking strategies aimed at enhancing patient engagement, resulting in a 73% increase in retention rates across 3 clinical studies.
  • Provided key input in the strategic design of clinical trials, directly contributing to a 28% increase in patient engagement.
  • Spearheaded the execution of international multi-center clinical trials involving 15 sites, ensuring compliance with ICH GCP Guidelines.
  • Achieved a President's Club for category by ensuring zero critical findings during regulatory inspections of 17 clinical sites.
  • Collaborated with the data management team to refine data collection processes, increasing data accuracy by 51%.
  • Collaborated with team of 8 in the development of category.
  • Streamlined processes across 14 clinical research teams, leading to a 18% reduction in trial start-up times.
  • Collaborated with key opinion leaders and advisory boards to refine trial design, resulting in a 83% uptick in patient recruitment metrics.

Affiliations

  • Association for Computing Machinery
  • Society for Translational Research
  • World Medical Association (WMA)
  • Academy of Clinical Research Professionals (ACRP)
  • International Association of Administrative Professionals
  • Association of Information Technology Professionals
  • American Society of Safety Professionals
  • American Marketing Association
  • Toastmasters
  • International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Certifications

  • ISO 9001 Quality Management Systems Certification (Ironclad Systems, 2019)
  • Advanced Biotech Regulatory Affairs Certification - 2017
  • Certified Business Analysis Professional (CBAP)
  • Project Management Professional (PMP)
  • CompTIA Security+
  • Apple Certified Associate (ACA)
  • Device and Drug Combination Products Certification - Northwind - 2020
  • Google Certified Professional Cloud Architect
  • FDA 21 CFR Part 11 Compliance Certification - 2018
  • EClinical Technology Certification Workday - 2024

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