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Principal Clinical Data Scientist

4 hours, 22 minutes ago
Serbia, Slovakia, Spain, United Kingdom, Poland, Romania, Hungary
Full-time
Lead
Data Scientist
Data Science and Analytics
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 93

Description

  • Lead CSAI services according to study scope of work across assigned projects.
  • Support scientific data capture, review, cleaning, visualization, and cross-functional data review processes.
  • Manage Medical Monitor review of subject data and provide scientific operational protocol review.
  • Partner with Data Management on eCRF specifications, edit checks, completion guidelines, EDC UAT, and study documentation.
  • Conduct or oversee holistic and aggregate clinical data reviews using programmed outputs, listings, quality metrics, and graphs.
  • Manage queries, review findings, provide status updates, and escalate study risks or deficiencies.
  • Develop and maintain CSAI plans, guidelines, trackers, programmed outputs, and associated UAT.
  • Provide study-specific training and participate in internal and external meetings, presentations, and data-related committees.
  • Support CSAI budgeting, invoicing, resource planning, eTMF maintenance, process improvements, SOPs, and departmental training.

Requirements

  • Bachelor’s degree or equivalent education and experience in a science or health-related discipline, with medical terminology proficiency.
  • At least 8 years of clinical research experience or demonstrated equivalent competencies.
  • At least 1 year of leadership experience.
  • Experience with electronic data capture systems and Microsoft Office applications.
  • Advanced oncology and medical terminology knowledge, including disease assessment criteria, standards of care, and grading criteria.
  • Working knowledge of FDA regulations, ICH-GCP, SOPs, regulatory guidance, and clinical research processes.
  • Strong communication, presentation, organization, analytical, critical-thinking, decision-making, negotiation, and conflict-management skills.
  • Ability to independently lead CSAI operations in global, cross-functional, and remote environments, with occasional domestic and international travel.
  • Preferred qualifications include a medical degree or credential, database build or monitoring experience, JReview or similar data visualization experience, and experience with solid and liquid tumors, Phase I–III, or global trials.
  • Candidates must be legally authorized to work in the country of employment without employer sponsorship.

Interested in this position?

Apply directly on the company website

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