Manager of Clinical Data Management - Remote

Overview

The Manager of Clinical Data Management role at Oruka Therapeutics is responsible for overseeing clinical data management activities, ensuring compliance with regulatory standards, and supporting the clinical development program.

In Short

• Lead data management for 3-4 clinical studies.
• Oversee data management CRO activities from database start-up to lock.
• Develop study timelines and ensure deliverables are met.
• Manage the development of clinical databases and key data management documents.
• Participate in the development of ePRO/eCOA systems.
• Ensure data quality for statistical reviews and database locks.
• Conduct internal reviews and maintain data management logs.
• Participate in audits and inspections.
• Provide input on data management SOPs and templates.
• Work with various functions to ensure effective communication.

Requirements

• Bachelor’s degree in a science or IT-related field.
• 8+ years of clinical research experience, with 5-6 years in data management.
• Familiarity with CDISC/CDASH and international coding dictionaries.
• Experience with EDC software and electronic trial master files.
• Strong organizational and project management skills.
• Excellent verbal and written communication skills.
• Ability to work independently and handle multiple tasks.
• Knowledge of regulatory requirements and clinical trial processes.
• Experience with CRO vendor oversight.
• Critical thinking and problem-solving skills.

Benefits

• Competitive salary and equity package.
• Performance-related bonus opportunity.
• Supportive and inclusive team environment.
• Opportunities for professional growth and development.
• Impactful work in a vibrant startup culture.