Principal Clinical Data Scientist

About the role

The Principal Clinical Data Scientist leads the Clinical Science Analytics & Insights function, overseeing data collection, cleaning, and visualization from study start‑up through database lock. This role serves as the subject‑matter expert on clinical guidelines and standards of care, ensuring high‑quality data review within a cross‑functional team.

Key responsibilities

• Lead CSAI services per study scope, acting as the functional lead for assigned projects.
• Manage cross‑functional data cleaning processes, including tiered cleaning timelines and medical monitor review.
• Provide scientific and clinical input to data management for eCRF specifications, edit checks, and UAT support.
• Develop and maintain project plans, trackers, and eTMF documentation in line with SOPs.
• Conduct holistic scientific data reviews using tools such as Smart Patient Profiles™ and generate status updates and queries resolution.
• Support project financial management, invoicing, and budget variance tracking.

Required profile

• Minimum 8 years of clinical research experience and at least 1 year of leadership experience.
• Strong knowledge of oncology, medical terminology, FDA/ICH‑GCP regulations, and clinical trial processes.
• Excellent communication, organization, and analytical skills with ability to work remotely and manage global cross‑functional teams.

Required skills

• Experience with electronic data capture (EDC) systems.
• Proficiency in Microsoft Office suite (Outlook, Word, Excel, PowerPoint).
• Experience with data visualization software such as JReview.