Principal Clinical Data Scientist

Precision for MedicineClinical research

Remote, Hungary; Remote, Poland; Remote, Romania; Remote, Serbia; Remote, Slovakia; Remote, Spain; Remote, United KingdomFull-TimePrincipal

Salary not disclosed

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Job Details

Languages: Professional use of the English language; both written & oral
Experience: Minimum of 8 years of clinical research experience or proven competencies for this position; minimum of 1 year of leadership experience
Required Skills: Microsoft Office

Hold a bachelor’s degree or have an equivalent combination of education and experience in a science or health-related discipline.
Have proficiency in medical terminology.
Have at least 8 years of clinical research experience or demonstrated equivalent competencies.
Have at least 1 year of leadership experience.
Have experience with electronic data capture systems.
Have experience with Microsoft Office products, including Outlook, Word, Excel, and PowerPoint.
Use English professionally in written and oral communication.
Be able to travel occasionally, domestically and internationally, including overnight stays.
Demonstrate advanced knowledge of oncology, medical terminology, disease assessment criteria, standards of care, and grading criteria.
Have working knowledge of FDA and ICH-GCP, relevant SOPs, regulatory guidance, and clinical trial processes.
Be able to manage operational work independently in a global, cross-functional environment and apply risk management.
Demonstrate organization, attention to detail, analytical thinking, time management, decision-making, negotiation, and conflict-management skills.

Lead implementation of Clinical Science Analytics & Insights services according to the study scope of work.
Advise project teams on scientific data capture, review, and cleaning.
Support cross-functional data-cleaning processes for interim and final study deliverables.
Manage medical monitor review of subject data and provide scientific operational protocol review.
Provide clinical and indication-focused input on eCRF specifications, edit checks, completion guidelines, and EDC user acceptance testing.
Conduct scientific clinical data review using defined guidelines and programmed outputs, including patient profiles, listings, metrics, and graphs.
Oversee or issue and resolve queries in EDC systems and manage development and user acceptance testing of programmed outputs.
Maintain study plans, guidelines, trackers, and applicable eTMF documentation; report review findings and escalate issues.
Train CSAI scientists, project teams, or study sites based on review findings.
Support study risk management, budget and resource planning, team meetings, and process improvement initiatives.

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