Principal/Senior Clinical Data Scientist

The role

The Principal/Senior Clinical Scientist leads the clinical science function for Oncology, Rare Diseases, and/or Autoimmune clinical development programs. You will provide scientific expertise to support the collection, review, and interpretation of clinical trial data.

What you will do

• Serve as a functional team lead for assigned projects from study start through database lock.
• Perform individual and aggregate participant data review using proprietary and non-proprietary tools.
• Act as a scientific and clinical data subject matter expert for study teams.
• Guide eCRF design, data capture requirements, edit checks, and EDC UAT.
• Support Risk Based Quality Management by identifying and addressing study risks and trends.
• Collaborate with Medical Monitoring and oversee Medical Monitor review of participant data.
• Provide protocol review from a scientific operational perspective.
• Support Project and Financial Management invoicing and out of scope management.
• Oversee and develop Clinical Science project plans, guidelines, and trackers.
• Participate in internal and external study-specific team meetings and presentations.

Required qualifications

• Bachelor’s degree or equivalent combination of education/experience in science or health-related discipline
• Proficiency with medical terminology
• Minimum of 8 years of clinical research experience or proven competencies
• Minimum of 3 years Oncology experience within the past 1.5 years
• Minimum of 1 year of leadership experience
• High Proficiency with Microsoft Office Products
• Excellent organization, communication, and interpersonal skills
• Professional use of the English language, both written and oral
• Ability to occasionally travel domestically and internationally including overnight stays (up to approximately 25%)
• Working knowledge of Oncology and clinical research standard criteria (e.g.: CTCAE, ASTCT, RECIST 1.1., Lugano, ICANS, etc.)
• Working knowledge of FDA and ICH-GCP, relevant SOPs and regulatory guidance

Nice to have

• Medical related degree, RN, OCN, RPH, PharmD, etc.
• Experience with Electronic Data Capture (EDC) systems
• Database build experience
• On-site experience (nurse, study coordinator, etc.), monitoring, and/or data review experience
• Experience with data visualization platform(s)/software(s) as data review tools
• Experience in phase I, II and III studies and global studies

About the company

Precision Medicine Group is an Equal Opportunity Employer.