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Skills

  • Data collection and analysis
  • Project organization
  • Team building
  • Adaptive trial design
  • Customer service
  • Regulatory compliance
  • Vendor management
  • Audit preparation and execution
  • Problem resolution
  • Process improvement

Work Experiences

  • Improved filing systems for confidential client records and reports increased operational efficiency.
  • Planned marketing initiatives and tapped into my referral network to promote business development.
  • Led the company to a successful product launch and growth by developing an initial product roadmap and go-to-market strategy.
  • Increased productivity by 4% while lowering staffing and operational costs.
  • Established, enforced, and optimized internal policies to maintain efficiency and responsiveness to demands.
  • Achieved a 46% improvement in team productivity.
  • Achieved full compliance during 2022 regulatory inspections.
  • Drove year-over-year business growth while leading operations, strategic vision, and long-range planning.
  • Assured consistent data quality across 9 globally-managed trials, achieving a 65% reduction in data queries from initial submissions.
  • Created procedure and program reports on a regular basis to evaluate performance, adjust strategies, and keep operations agile and sustainable.

Summaries

  • Professional with over 7 years of experience as a manager for a $6 two years revenue-generating company.
  • Strengths in strategic planning and performance reporting backed up by Miscellaneous training.
  • Dedicated to improving employee engagement and performance through training, monitoring, and morale-building.
  • Study Manager who is proactive and meticulous, with over 15 years of experience in the initiative industry.
  • Study Manager with 5 years of successful performance reporting and risk assessment experience.
  • Costs were consistently reduced while profits were increased.
  • Accelerated trial progression ahead of projections.
  • Collaborative, with a commitment to collaborating with coworkers to foster an engaged, empowering work environment.
  • Forward-thinking manager with 5 years of manufacturing project management experience.
  • Results-oriented, goal-oriented, and looking to apply my experience to the role of Study Manager.

Accomplishments

  • Managed clinical timelines for 16 ongoing studies, achieving 85% adherence to milestones and deliverables.
  • Worked with regulatory stakeholders from Austin to negotiate study protocol approvals, reducing submission timeline by 65%.
  • Integrated adaptive trial designs into clinical studies, leading to Power BI approval three years ahead of initial projection.
  • Collaborated with CROs and vendors to deliver clinical program milestones within 6 months, reducing trial delays by 32%.
  • Implemented comprehensive training programs for 17 research site personnel, substantially improving their adherence to study protocol.
  • Coordinated 13 multi-center clinical trials in Austin, ensuring consistency and compliance across international regulatory frameworks.
  • Managed the submission of 12 IND/CTA filings, securing approvals the past year ahead of schedule in collaboration with standard.
  • Trained 17 research sites on GCP compliance, resulting in zero critical audit findings during OSHA evaluations.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Optimized protocol development processes, reducing revision cycles by 79% and accelerating start-up timelines.

Affiliations

  • International Association of Contract Research Organizations (ACRO)
  • Collaborative Institutional Training Initiative (CITI)
  • Society of Human Resource Management
  • Association of Contract Research Organizations (ACRO)
  • Clinical Research Examiners Association (CREA)
  • International Academy of Clinical Research (IACR)
  • American Medical Informatics Association
  • International Society for Medical Publication Professionals (ISMPP)
  • European Society for Clinical Trials (EUCTR)
  • American Society of Safety Professionals

Certifications

  • CompTIA Network+
  • ICH GCP Investigator Site Training Certification - Northwind
  • Organizational Change Management Certification - 2021
  • ServSafe
  • Certified Clinical Research Coordinator (CCRC) initiative
  • Certified Professional in Healthcare Quality (CPHQ) - standard
  • Certified Clinical Data Manager (CCDM) - metric
  • Clinical Research Associate (CRA) Certification - method
  • Certified Public Accountant
  • Project Management Professional (PMP)

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