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Skills

  • Multidisciplinary teamwork
  • MS Office
  • Debt management
  • Team building
  • Supervision
  • Relationship development
  • Cost savings options
  • Risk mitigation strategies
  • Project organization
  • Clinical research manuscript editing

Work Experiences

  • Collaborated with Harbor & Co. On external review audits.
  • Collaborated with cross-functional teams.
  • Authored and peer-reviewed clinical summaries for Salesforce to support multilingual regulatory submissions across 5 regions.
  • Consulted with key opinion leaders to incorporate feedback on trial designs, improving the quality and relevance of clinical outcomes for system.
  • Conducted reviews for global submissions.
  • Collaborated with cross-functional teams to assess the safety and efficacy of ServiceNow, contributing to expedited product approvals.
  • Assessed clinical research manuscripts for publication.
  • Answered 11 calls per two years to help customers with their questions and concerns.
  • Oversaw the quality assurance program, which included on-site assessments, internal audits, and customer surveys.
  • Contributed to industry awareness on best practices.

Summaries

  • Comprehensive knowledge of regulatory submissions.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Boosted team productivity.
  • Clear understanding of strategic planning and budget management as well as team leadership training.
  • Clinical Reviewer with a strong background in global submissions, ensuring clinical trial data meets international regulatory requirements.
  • Collaborated with system.
  • Clinical Reviewer experienced in medical literature evaluation, leading 15 updates in safety protocols to enhance corporate clinical safety standards.
  • Recognized for motivating management team members to achieve their goals and fostering innovative work environments.
  • Adept Clinical Reviewer.
  • Adept Clinical Reviewer in facilitating cross-functional communication for clinical submissions, streamlining coordination across 6 markets.

Accomplishments

  • Managed clinical team review timelines effectively, which resulted in an on-time submission of standard to category ahead of prescribed deadlines.
  • Documented and resolved system which led to program.
  • Increased the accuracy rate of clinical trial data interpretation by 17%, reducing the need for resubmissions.
  • Streamlined the manuscript review process for clinical publications, enhancing collaboration with authors and reviewers, leading to a 69% increase in timely submissions.
  • Collaborated on post-submission responses for regulatory agencies, reducing time to approval by 10 weeks compared to previous submissions.
  • Collaborated with team of 15 in the development of procedure.
  • Implemented a new protocol for tracking trial data discrepancies, which reduced re-verification workload by 66%.
  • Established a clinical review process that reduced document errors by 25%, improving overall regulatory submission quality.
  • Optimized clinical data review protocols, reducing review cycle time by 17 days, leading to faster submission approvals.
  • Resolved product issue through consumer testing.

Affiliations

  • Clinical Research Forum Member
  • International Conference on Harmonisation (ICH) Working Groups
  • Institute of Clinical Research (ICR)
  • International Association of Statistics in Clinical Trials (IASCT)
  • Jaycees
  • Medical Device and Clinical Research Consortium
  • Association for Regulatory and Clinical Scientists (ARCS)
  • Institutional Review Board (IRB) Membership
  • Association for Clinical Research Professionals (ACRP)
  • Clinical Safety and Data Management Network

Certifications

  • First Aid/CPR Certified
  • Medical Writing & Editing Certification - 2021
  • Apple Certified Associate (ACA)
  • Certified Clinical Trial Auditor (CCTA) - 2019
  • ServSafe
  • Certified Clinical Documentation Improvement Practitioner (CDIP) - 2018
  • Certified Professional in Healthcare Quality (CPHQ) 2019
  • Certified Clinical Trial Professional (CCTP) - Brightline
  • Health Information Privacy & Security (HIPS) Certification - Summit Group
  • CompTIA Security+

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