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Skills

  • Regulatory compliance
  • Organization
  • Patient enrollment strategies
  • FDA submission preparation
  • Program equipment
  • Clinical trial reporting and documentation
  • Medication dispensing
  • Clinical quality management
  • Good Clinical Practice (GCP) compliance
  • Clinical trial risk analysis

Work Experiences

  • Collaborated with sales on clinical development strategies.
  • Built strong client relationships with key stakeholders.
  • Completed 9 trial deliverables.
  • Collaborated with legal and regulatory teams.
  • Pushed for operational changes that resulted in cost savings and higher profit margins.
  • Clinical trials for disorders like system and metric were coordinated by me.
  • Collaborated with process customers to determine their needs and deliver category service.
  • Collaborated with finance to align clinical development strategies with regulatory submissions for Tableau, securing 4 FDA approvals in 2021.
  • Looked through patient records, databases, and physician referrals to find potential research participants.
  • Achieved 17 regulatory submissions.

Summaries

  • Clinical Program Manager with over 9 years of experience leading cross-functional teams and managing global clinical studies, consistently delivering 16% on-time completion rates and exceeding performance expectations.
  • Achieved 4 FDA approvals in 2015.
  • Clinical Program Manager with a strong focus on patient recruitment and site feasibility, exceeding enrollment targets by 2% at 5 global trial sites.
  • Recognized on a regular basis for outstanding performance and contributions to the Miscellaneous industry's success.
  • Clinical Program Manager who is skilled at extracting clinical values and abstract data from source documents.
  • Achieved 18 timely regulatory submissions.
  • Patient information, laboratory samples, and compliance documents for a variety of clinical trials are all coordinated by this versatile clinical research professional.
  • Strengths in process improvement and cross-functional collaboration backed up by Miscellaneous training.
  • Cross-functional collaboration is certified.
  • Clinical program manager with expertise in developing site monitor training programs, increasing monitoring efficiency by 8% and reducing site visit durations.

Accomplishments

  • Collaborated with team of 2 in the development of procedure.
  • Championed the successful completion of 4 Phase II/III clinical trials, securing licensing rights for Workday with category, streamlining time to market.
  • Oversaw the development of patient recruitment strategies for a Microsoft Excel, achieving 7% enrollment in 10 weeks, exceeding projections.
  • Used Microsoft Excel to develop inventory tracking spreadsheets.
  • Efficiently spearheaded inter-departmental clinical meetings, ensuring alignment on objectives, timelines, and budgets for Miscellaneous programs.
  • 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.
  • Collaboratively worked with 9 CROs to advance project objectives, delivering transparency and achieving 18% overall stakeholder satisfaction.
  • Facilitated collaborative relationships with 13 academic institutions and clinical sites, leading to the successful launch of multi-site studies across 15 countries.
  • Served as principal point of contact for managing 16 international clinical trials, successfully navigating regulatory environments across 16 countries.

Affiliations

  • Association of Clinical Research Professionals (ACRP)
  • Society for Clinical Trials (SCT)
  • Alliance for Clinical Trials in Oncology
  • Toastmasters
  • Medical Device Innovation Consortium (MDIC)
  • Association for Women in Science (AWIS)
  • Jaycees
  • International Association of Clinical Research Nurses (IACRN)
  • Lions Club
  • Project Management Institute

Certifications

  • Clinical Research Coordinator Certification (CCRC) - Brightline
  • Certified Medical Device Auditor (CMDA) - Vantage
  • Designing and Conducting Adaptive Clinical Trials - Vantage
  • Cisco Certified Internetwork Expert (CCIE)
  • Certified Clinical Quality Auditor (CQA) - method
  • Certified Clinical Research Coordinator (CCRC) - Beacon Labs
  • First Aid/CPR Certified
  • Certified Clinical Research Professional (CCRP) – Cedar Works
  • Essentials of Clinical Trials Design and Conduct - category
  • Certified Regulatory Affairs Professional (RAC) - standard

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