Teams at Oruka Therapeutics

Coordinate biosample operations across clinical trials, including collection, shipment, reconciliation, chain-of-custody documentation, laboratory transfers, vendor oversight, and data quality review. Support study startup, audit readiness, issue resolution, reporting, and process improvement while collaborating with clinical operations, laboratories, vendors, and cross-functional biotech teams.

Maintains electronic Trial Master Files throughout clinical studies, ensuring accurate, complete, timely, compliant, and inspection-ready documentation. Performs TMF quality control, reconciliation, health metric monitoring, issue resolution, vendor and CRO coordination, audit and inspection preparation, and process improvement. Supports TMF plans, SOPs, training, system adoption, and continuous compliance with ICH-GCP, regulatory requirements, and company procedures.

Supports Clinical Pharmacology and Nonclinical development programs by managing project timelines, deliverables, meetings, reviews, vendors, budgets, contracts, and operational tools. The role coordinates cross-functional activities, tracks risks and action items, facilitates document approvals, and improves project management processes. Candidates should have scientific or technical training, pharmaceutical or biotech experience, strong communication skills, and proficiency with project management tools.