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Kerise LyttleKL
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Kerise Lyttle

@keriselyttle

Project management professional specializing in biopharmaceutical clinical operations.

Japan
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What I'm looking for

I seek a senior project or program role in clinical or biopharma settings where I can lead cross-functional teams, drive regulatory-compliant delivery, improve processes, and manage end-to-end clinical supply or implementation programs.

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.

Experience

Work history, roles, and key accomplishments

BJ

Assistant Project Manager

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.

SM

R&D Scientist

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.

Education

Degrees, certifications, and relevant coursework

Hokkaido University logoHU

Hokkaido University

Doctor of Philosophy, Neuropharmacology

Completed a PhD in Neuropharmacology with research focused on neuropharmacological mechanisms and preclinical study methodologies.

Ehime University logoEU

Ehime University

Master of Science, Psychopharmacology

Completed a Master's degree in Psychopharmacology involving advanced study and research in psychopharmacological principles and experimental methods.

University of the West Indies logoUI

University of the West Indies

Bachelor of Science, Basic Medical Science

Earned a Bachelor of Basic Medical Science providing foundational knowledge in biomedical sciences and laboratory techniques.

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Kerise Lyttle - Clinical Supply Manager - Almac Clinical Services | Himalayas