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A highly experienced professional with over 20 years in research, specializing in clinical trials. Leveraging a Doctorate in Medicine, Project Management Professional (PMP) certification, and ACRP-CRA credential, they deliver successful local and global studies for various clients.
Key Skills:
Clinical Operations & Project Leadership: Proven expertise in managing all aspects of clinical trials, including study plans, protocols, site monitoring, data review, and budget management.
Clinical Development: Experience in protocol development, investigator interactions, data analysis, and regulatory submissions.
Safety Management: Skilled in identifying and investigating safety signals, managing clinical trial data, and interacting with regulatory agencies (FDA, TGA) on safety matters.
Project Management: Adept at leading cross-functional teams, creating project plans, managing resources, and ensuring adherence to timelines and budgets.
Communication & Collaboration: Excellent communication and interpersonal skills, fostering strong relationships with investigators, study teams, and stakeholders.
Experience Highlights: Vergent Bioscience, Syneos Health , Daiichi Sankyo, Inc., Precision for Medicine, NJ, AstraZeneca/MedImmune
Proven Track Record:
This individual has a proven track record of successfully managing clinical programs for major pharmaceutical companies. Their expertise spans all phases of clinical development, ensuring studies are conducted efficiently and meet regulatory requirements. Schedule a free Consultation Now.