Diane Beaudry

Background

About Diane Beaudry

I am a driven, resourceful bilingual project manager and scientist with extensive experience in non-GLP and GLP preclinical studies of medical devices and drug metabolism and pharmacokinetics (DMPK). Courteous, customer service-oriented professional, recognized for team spirit, sense of priorities, attention to detail, timely deliverables and excellent writing and listening skills. Influential, collaborative leader with excellent communication skills dedicated to upholding ethical standards, safeguarding research subjects' well-being, and ensuring precision in data interpretation and reports. As a Scientific Director, I managed a team of 14, overseeing science operations including work scheduling, protocol writing, resource utilization, change initiatives, study direction, result compilation, analysis, report writing, presenting study rationale to ethics committees and deadline compliance. I ensured strict adherence to protocol, SOPs, and regulatory guidelines, participated in client meetings, FDA interactions, and client visits. Involved in SOP redaction/revision, peer-review of scientific documents, and demonstrated leadership in guiding, developing, and mentoring junior scientists. Taking on the role of Study Director under 21 CFR Part 58.33, I was responsible for the design, supervision, and reporting of study-related procedures in preclinical studies incorporating newly developed medical devices while meeting time constraints. Ensured precise execution as per the protocol, SOPs, and regulatory guidelines. Ensured communication with all departments and clients regarding study progression, aided in the training, coaching, and growth of new employees, and participated in the drafting/revision of SOPs. Confirmed study personnel received proper materials and instructions. Engaged in the review and revision of abstracts/publications. I have great enthusiasm for research aimed at providing revolutionary health solutions to enhance the prevention and treatment of diseases in both human and animal populations. In my client-focused role, I effectively supported sponsors in achieving objectives by consistently demonstrating leadership qualities, honoring milestones, and maintaining an unwavering commitment to upholding the highest ethical standards.