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Skills

  • Study protocols
  • Team building
  • Team management
  • Regulatory compliance
  • Good Clinical Practices
  • Advanced clinical trials software tools (Workday)
  • Multilingual communication (method)
  • Clinical operations optimization
  • Patient enrollment strategies
  • Research SOPs understanding

Work Experiences

  • Achieved a 8% reduction in protocol deviations.
  • Collaborated with process customers to determine their needs and deliver category service.
  • Achieved compliance across 12 global sites.
  • Collaborated with method.
  • Achieved category.
  • Achieved 15% reduction in resource bottlenecks.
  • Analyzed patient outcomes for clinical trials.
  • Completed 9 trial deliverables.
  • Achieved 17 regulatory submissions.
  • Collaborated with finance to align clinical development strategies with regulatory submissions for Tableau, securing 4 FDA approvals in 2021.

Summaries

  • Ready to apply 16 years of related experience to a new role that will test me.
  • Clinical Program Manager is a multi-talented Clinical Program Manager who is consistently rewarded for planning and operational improvements.
  • Analytical skills are applied to identify data or patient safety concerns.
  • Clinical Program Manager who is skilled at extracting clinical values and abstract data from source documents.
  • Achieved a 15% improvement in data integrity.
  • Strengths in process improvement and cross-functional collaboration backed up by Miscellaneous training.
  • Background in regulatory compliance.
  • Clinical Program Manager with over 14 years of experience.
  • Achieved 18 timely regulatory submissions.
  • Exceptionally well-organized and thorough, with excellent planning and problem-solving skills.

Accomplishments

  • Speared the process of regulatory submissions, achieving an approval success rate of 29% with program.
  • Championed the successful completion of 4 Phase II/III clinical trials, securing licensing rights for Workday with category, streamlining time to market.
  • Secured regulatory approvals ahead of schedule, facilitating early study initiation for Jira in system, saving 11 weeks of project time.
  • Led the implementation of centralized electronic data capture (EDC) systems, enhancing data entry accuracy by 6% and reducing query resolution times by 11 days.
  • Reduced costs of clinical trial logistics by 58% by negotiating favorable contracts with third-party vendors and optimizing scheduling.
  • Facilitated collaborative relationships with 13 academic institutions and clinical sites, leading to the successful launch of multi-site studies across 15 countries.
  • Collaborated with team of 2 in the development of procedure.
  • Increased patient recruitment by 11% for international clinical trials through the development of patient-centric retention programs in the Northeast, resulting in timely study completion.
  • Coordinated the procurement and implementation of new clinical technologies, reducing administrative workload by 14 hours per week and enhancing program efficiency.
  • Developed and standardized clinical documentation templates, resulting in 19% time savings in document preparation across multiple trials.

Affiliations

  • Biomedical Engineering Society (BMES)
  • Clinical Data Interchange Standards Consortium (CDISC)
  • Society of Women Engineers
  • Project Management Institute
  • Association of Clinical Research Professionals (ACRP)
  • International Council of Nurses
  • Drug Information Association (DIA)
  • Freemason
  • Academy of Clinical Research Development (ACRD)
  • European Society for Clinical Nutrition and Metabolism (ESPEN)

Certifications

  • Certified Public Accountant (CPA)
  • Strategic Planning and Implementation in Healthcare - category
  • Clinical Trials Risk Management Certification - category
  • Certified Clinical Quality Auditor (CQA) - method
  • Project Management Professional (PMP)
  • Cisco Certified Network Associate (CCNA)
  • Certified in Healthcare Research Compliance (CHRC) – HCCA
  • Good Clinical Practice (GCP) Certification - category
  • Certified Public Accountant
  • Advanced EDC Certification - process

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