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Kura Oncology is looking to solve the problem of cancer treatment through the discovery and development of precision medicines, specifically by improving the science of cancer treatment and developing precision medicine therapeutics.

Requirements

• Experience in data management or relevant work in the pharmaceutical/biopharma industry.
• Experience in managing DM activities throughout the study lifecycle (planning, start-up, conduct, close-out)
• Significant experience providing oversight for database migrations.
• Experience with an NDA submission desirable
• Experience working in 1 or more EDC platforms (Rave, InForm, etc.).
• Experience working in a data integration/visualization platform (e.g. Saama, elluminate) desirable
• Solid understanding of clinical drug development process and knowledge of regulatory requirements and ICH/GCP guidelines.

Responsibilities

• 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.

Other

• A./B.S. degree in Biology, Mathematics, Computer Science or related scientific field.
• 5+ years’ experience in data management or relevant work in the pharmaceutical/biopharma industry.
• Flexibility to travel up to approximately 5% of the time.
• Excellent interpersonal skills in addition to verbal and written communication skills.
• Ability to work as part of a team and contribute to the development of departmental procedures documentation.