Kura Oncology, Inc.

QA Engineer

• Develop collaborative partnerships with clinical study teams/study team leaders to maintain a current understanding of potential areas of quality risk exposure within the context of ongoing clinical studies and across clinical programs as assigned.
• Ensure compliance with clinical quality assurance activities including facilitating and managing internal and external GCP audits/audit programs, as applicable.
• Implement and support QA activities that foster an outcome of compliance and adherence to relevant laws, regulations, guidance; upholds the rights and welfare of patients; is focused on data integrity and end to end quality assurance
• Assist in identifying opportunities for process improvement initiatives, including process/program reviews to identify approaches that will prevent quality issue recurrence (e.g. issue escalation and management; and applicable corrective/preventative action programs, periodic internal audit/gap assessment).
• Assist with the development and tracking of trending and metrics of internal as well as external vendor quality issues.
• Provide related training on new regulatory requirements and industry practices.
• Lead and manage clinical inspection readiness activities for assigned programs and other key programs as applicable.
• Support Regulatory Inspections of Kura Oncology products, including supporting/facilitating back room and front room activities and supporting the drafting/reviewing of responses to regulatory authority findings, as applicable.
• Promote quality and risk management principles (e.g., quality by design, critical to quality focuses, risk assessment and risk ranking, establishment of risk thresholds and tolerance limits) when supporting innovative programs and advancing ongoing clinical programs.
• Maintain accountability for ensuring risk-based strategies are utilized when managing and mitigating quality issues and supporting clinical studies, ensuring study-specific risk management activities and strategies are utilized consistently across programs.

Associate Director, Clinical Quality Assurance

Data Scientist

• Provide clear, consistent communication to Kura’s CROs and 3rd party Vendors with respect to data management deliverables and monitor performance against communicated expectations.
• Coordinate internal team review and feedback during EDC builds and/or migrations and provide clear guidance to external DM and EDC build team throughout.
• Accountable for DM task and milestone timelines
• Responsible for ensuring data quality and integrity for clinical study data collection activities.
• Work with clinical team to define and maintain the Kura Comprehensive Data Review Plan.
• Lead Kura study team in the review of clinical study data per Comprehensive Data Review Plan.
• Prepare and provide internal data listings and reports as required.
• Review protocols for data collection and management feasibility.
• Provide leadership to the study team with respect to data management activities throughout the study lifecycle: planning, start-up, conduct, close-out.
• Accountable for the creation and delivery of DM documentation (i.e., eCRFs, CCGs, DMP, Data Transfer Specifications, etc.); ensure documentation is appropriately filed within the Trial Management File (TMF).
• Review study budgets and provide input on data collection, cleaning, and reporting as it relates to development of vendor contracts.
• Partner with internal content experts to manage and coordinate data collection/maintenance with external vendors; ensure deliverables are identified and met according to project milestones and program/project objectives.
• Responsible for tracking and documenting data management decisions.
• Responsible for initiating and chairing meetings associated with assigned studies and initiatives
• Provide support and contribute to the development of clinical trial timelines as it relates to data management activities.
• Manage accruals tracking and vendor payments for data management activities.
• Contribute to the development of departmental procedures documentation.
• Complete other duties as assigned by the.

Associate Director, Clinical Quality Assurance

Manager/Senior Manager, Clinical Data Sciences