I thrive on communication. This theme runs through everything I do, including running multi-national clinical program teams, maximizing the use of information technology in both my business and personal life, and passionately seeking out new ideas and information to share with others. My background in medical research has given me the tools necessary to succeed in the field of clinical operations, while my skills and interest in technology continue to drive me towards new ways to connect and interact with others.
As we move into a new era of drug development, I am increasingly interested in leveraging technology to streamline and decentralizalize clinical trials. This includes wearable devices, remote monitoring, EMR access, and solutions in digital health.
Some specifics about me:
• Over 20 years expertise in Clinical Program Management and Operations at Pharma, Biotech, CRO, and Service Providers.
• Demonstrated success in hands-on problem solving and decision-making.
• Successful management of complex national and international Phase I through IV clinical trials and registries.
• Experienced in managing NDA and BLA preparation.
• Proven analytical skills in process development, technology integration, and training.
• Experienced in protocol development and review, budgeting, and time management.
• In-depth knowledge of Internet research resources and web interfaces.
• Highly proficient at Microsoft Office Suite, including Outlook, Excel, Word, and PowerPoint.
• Strong leadership, interpersonal, communication, and presentation skills, with supportive attitude.
• Bilingual in English and French.
Specialties: Phase I to IV clinical trials in multiple therapeutic areas, Patient Registries, Study Protocol Development, EDC (Electronic Data Capture), IVR (Interactive Voice Response), IST (Investigator Sponsored Trials), TMF (Trial Master Files), SOP development and process improvement, Budget Management, Software Training, Web Research, Broad Technical Knowledge.