Principal Clinical Research Scientist # 4365

Responsibilities:

• Collaborate with key functional stakeholders on the design, conduct and analysis of clinical studies conducted with GRAIL’s academic, community, and industry partners
• Design and implement systematic approaches to review, clean, analyze and integrate large and complex clinical datasets from one or more large clinical studies
• Provide regular and ad-hoc data reviews and interpretation of clinical data; prepare and present summaries/documentations of these reviews to share with cross-functional teams
• Participate in data quality review activities and efforts to resolve data quality issues.
• Support efforts to advance the clinical development and scientific plans (review and interpretation of study data; engagement of key opinion leaders; providing strategic and scientific input to study-level and program-level teams)
• Contribute to development of data collection forms and data/metadata standards to support clinical studies and pooled data analyses
• Collaborate with colleagues from Biostatistics to develop statistical analysis plans and serve as a co-author on clinical study reports and other study deliverables
• Represent Clinical Science as a strategic thought leader on cross-functional project teams with goals of building and deploying systematic approaches for data review, cleaning and analyses
• Contribute to methods to ensure data integrity and quality throughout the product development lifecycle, ensuring appropriate blinding and data privacy standards are followed.
• Develop electronic case report forms and other clinical data capture methods for clinical data acquisition and study subject follow-up
• Contribute to study reports, presentations, and publications of studies
• Conduct literature reviews and/or obtain external data (e.g., SEER, US Census)  as needed to inform or interpret GRAIL study results or statistical models.
• Develop formal networks with external investigators and thought leaders to support clinical study programs
• Ensure compliance with industry regulations, policies, guidelines and standards

Preferred Qualifications:

• Advanced clinical/scientific degree (e.g. PharmD, PhD, MSN, MPH)with at least 5 years of oncology clinical and/or population science research experience
• Minimum 5 years of experience working in industry, including deep experience in cancer epidemiology, especially as it relates to screening and early detection
• Experience with SEER or other population-based cancer registry data
• Experience in designing and conducting clinical and/or real-world evidence studies, particularly registrational and/or clinical utility studies for reimbursement
• Strong track record in data management and integrating complex, large-scale datasets.
• Knowledge of regulatory requirements (e.g. ICH, GCP, HIPAA)
• Demonstrated ability to initiate and maintain effective relationships with internal and external collaborators
• Excellent interpersonal communication (written and verbal), presentation and organizational skills
• Excellent team player with demonstrated track record of success in a fast-pace cross-functional team environment
• Consistent commitment to delivering on team goals with a sense of shared purpose