Manager/Senior Manager, Clinical Data Sciences

Role Summary

Manager/Senior Manager, Clinical Data Sciences at Kura Oncology. The role focuses on overseeing outsourced data management and EDC activities, coordinating internal study data reviews, and delivering fit-for-purpose clinical data to support study milestones in a oncology-focused biopharma environment.

Responsibilities

• Provide clear, consistent communication to CROs and 3rd party Vendors regarding data management deliverables and monitor performance against expectations.
• Coordinate internal team review and feedback during EDC builds/migrations and guide external DM/EDC build teams.
• Accountable for DM task and milestone timelines.
• Ensure data quality and integrity for clinical study data collection activities.
• Define and maintain the Kura Comprehensive Data Review Plan with the clinical team.
• Lead study team in review of clinical study data per the Comprehensive Data Review Plan.
• Prepare internal data listings and reports as required.
• Review protocols for data collection and management feasibility.
• Provide leadership to the study team for data management activities across the study lifecycle.
• Create and deliver DM documentation (eCRFs, CCGs, DMP, Data Transfer Specifications); file documentation in TMF.
• Review study budgets and provide input on data collection, cleaning, and reporting for vendor contracts.
• Coordinate data collection/maintenance with external vendors to meet milestones and objectives.
• Track and document data management decisions; initiate and chair study meetings.
• Support development of clinical trial timelines related to data management.
• Manage accruals tracking and vendor payments for data management activities.
• Contribute to departmental procedures documentation and complete other duties as assigned.

Qualifications

• B.S. in Biology, Mathematics, Computer Science or related field.
• 5+ years‚Äô experience in data management or related pharma/biopharma experience.
• Experience in oncology strongly preferred.
• Experience managing DM activities throughout the study lifecycle (planning, start-up, conduct, close-out).
• Significant experience overseeing database migrations.
• Experience with NDA submissions desirable.
• Strong project management and vendor management skills (biomarkers, labs, imaging, ECG).
• Ability to provide independent DM SME support to study teams and vendors.
• Experience with one or more EDC platforms (Rave, InForm, etc.).
• Experience with data integration/visualization platforms desirable (e.g., Saama, elluminate).
• Solid understanding of clinical drug development, regulatory requirements, ICH/GCP guidelines.
• Excellent planning, organization, time management, and communication skills.
• Strong Excel skills; SAS experience a plus.
• Ability to travel up to ~5%.

Skills

• Data management
• EDC systems (Rave, InForm, etc.)
• DM documentation (eCRFs, DMP, etc.)
• Vendor and project management
• Clinical data review and reporting
• Regulatory knowledge (ICH/GCP)

Education

• B.S. in a related scientific field