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@keriselyttle
Project management professional specializing in biopharmaceutical clinical operations.
I am a dynamic project management professional with over seven years' experience in the biopharmaceutical industry, specialising in clinical supply, biomedical imaging, and oncology-related projects. I lead cross-functional teams with a focus on delivering projects on time and within budget while maintaining compliance with regulatory frameworks.
My background spans end-to-end clinical supply chain management, software implementation, and infrastructure migration, where I have served as primary client liaison and managed multiple concurrent, high-complexity projects. I apply both Agile and Waterfall methodologies and employ tools such as Microsoft 365, Azure, JIRA, and Salesforce to drive execution and reporting.
I have a strong foundation in regulatory and quality frameworks (GCP, GLP, OECD, ICH, EMA, FDA, PDMA) and a proven record of risk management, budget oversight, and vendor coordination across global teams. I hold PMI certifications including PMP and Professional in Business Analysis, and additional training in Six Sigma, Lean, Kaizen, and Scrum/Agile.
Bilingual in English and Japanese, I combine analytical rigour with stakeholder-focused communication to ensure audit readiness and successful project outcomes in complex, regulated environments. I am motivated to lead initiatives that improve processes, reduce waste, and ensure patient-centric delivery of clinical trial supplies and services.
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Work history, roles, and key accomplishments
Almac Clinical Services
Nov 2024 - Present (1 year)
Manage end-to-end clinical supply chain operations for multiple concurrent trials, leading forecasting, procurement, manufacturing, labelling and global distribution to ensure on-time drug delivery while maintaining GMP and regulatory compliance.
Calyx Japan
May 2022 - Mar 2024 (1 year 10 months)
Managed a Japan portfolio of six high-complexity projects, overseeing contracts, budgets, vendors and Azure infrastructure migration while enforcing risk, quality and audit-readiness processes.
Signant Health
Oct 2021 - Mar 2022 (5 months)
Coordinated global teams to deploy healthcare software for clinical trials, managing finances, milestones and resource allocation to ensure on-time deployments across regions.
Edanz Japan
Dec 2019 - Oct 2021 (1 year 10 months)
Oversaw 20+ projects from inception to completion, managing budgets, quality assessments and stakeholder communications while onboarding and training global remote teams.
Bioclinica Japan
Mar 2019 - Nov 2019 (8 months)
Monitored multimillion-dollar projects using MS Office and CRM systems, maintained project documentation and communicated progress to global stakeholders to ensure regulatory compliance and timelines.
Sekisui Medical
Apr 2017 - Feb 2019 (1 year 10 months)
Facilitated stakeholder communications and managed study feasibility, vendor selection, resource allocation and document control for studies valued over US$6,000,000.
Sekisui Medical
Sep 2015 - Feb 2017 (1 year 5 months)
Conducted and supported 75+ preclinical and clinical Phase I–III studies, streamlining bioassay technologies and performing validation, data analysis and study documentation to meet regulatory standards.
Degrees, certifications, and relevant coursework
Doctor of Philosophy, Neuropharmacology
Completed a PhD in Neuropharmacology with research focused on neuropharmacological mechanisms and preclinical study methodologies.
Master of Science, Psychopharmacology
Completed a Master's degree in Psychopharmacology involving advanced study and research in psychopharmacological principles and experimental methods.
Bachelor of Science, Basic Medical Science
Earned a Bachelor of Basic Medical Science providing foundational knowledge in biomedical sciences and laboratory techniques.
Software and tools used professionally
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