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Skills

  • Category equipment
  • Data Accuracy & Integrity Enhancement
  • Clinical database management
  • Electronic Data Capture (EDC) system implementation
  • Operational improvement
  • Good Clinical Practices
  • Regulatory compliance
  • MS Office
  • FDA and EMA Regulatory Knowledge
  • Clinical trial risk assessment

Work Experiences

  • Ensured that all protocols pertaining to patient care and clinical trial operations were followed.
  • Coordinated cross-functional meetings.
  • Collected and analyzed performance metrics.
  • Authored and updated clinical operations SOPs, which contributed to Outstanding Service Award recognition for innovation in clinical trial efficiency.
  • Collaboratively worked with regulatory agencies to achieve IRB approvals in record time for a system study, increasing study start-up speed by 48%.
  • Collaboratively worked with regulatory agencies.
  • Had an excellent attendance record and was always on time for work.
  • Followed informed consent procedures and kept track of everything.
  • Achieved 18 IND approvals.
  • Collaborated with biostatisticians.

Summaries

  • Clinical Trial Manager with over 18 years of experience leading global clinical trials while consistently reducing costs by implementing efficient vendor management strategies.
  • Clinical Trial Manager with over 17 years of experience.
  • Exceptionally well-organized and thorough, with excellent planning and problem-solving skills.
  • Achieved record-time approvals.
  • Achieved zero major findings during the latest audit.
  • Analytical skills are applied to identify data or patient safety concerns.
  • Achieved results through comprehensive planning.
  • Client relations is certified.
  • Achieved Outstanding Service Award recognition by authoring innovative SOPs that revolutionized the efficiency of clinical operations.
  • Authored innovative SOPs.

Accomplishments

  • Led conflict resolution efforts with investigative sites, resolving compliance issues within framework, facilitating seamless continuation of trials.
  • Managed a portfolio of 16 clinical trials, ensuring 56% on-time trial completion and compliance with SOPs, GCP, and regulatory standards.
  • Developed risk management strategies throughout trial phases, successfully mitigating 9 key trial risks and ensuring on-time study delivery.
  • Created a patient compliance monitoring system, improving adherence to study drugs by 66% across 12 trials.
  • Led the implementation of a patient recruitment tool, resulting in a 59% increase in recruitment speed for SAP trials.
  • Established strategic patient retention initiatives that boosted retention rates by 17% for critical trials.
  • Contributed to the development of innovative patient-facing materials that improved patient education and compliance by 85%.
  • Coordinated 16 Phase 8 clinical trials, successfully enrolling 18 patients and maintaining high levels of participant engagement.
  • Collaborated with team of 10 in the development of program.
  • Developed financial accountability mechanisms that delivered a 49% reduction in trial budget overruns, achieving greater fiscal control.

Affiliations

  • Project Management Institute (PMI) – PMP Certification
  • International Clinical Trials Methodology Conference (ICTMC) Speaker
  • European Society of Clinical Pharmacy (ESCP)
  • International Society for Stem Cell Research (ISSCR) Affiliate
  • Trial Master File (TMF) Reference Model Group Membership
  • Association for Clinical Oncology Nursing (ACON)
  • Society for the Advancement of Clinical Trials (SACT)
  • National Association of Social Workers
  • Drug Information Association (DIA)
  • American Marketing Association

Certifications

  • Certified Business Analysis Professional (CBAP)
  • Vendor Oversight Certification for Clinical Trials
  • Certified Public Accountant (CPA)
  • Barnett GCP Training: Advanced Site Monitoring
  • Certified Regulatory Affairs Professional (CRAP)
  • Certificate in Clinical Trial Design and Management
  • Data Integrity in Clinical Trials Certification
  • Cisco Certified Internetwork Expert (CCIE)
  • Certificate in Patient Recruitment Strategies
  • Microsoft Certified Systems Engineer (MCSE)

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