Clinical Data Management Director

Summary

Join Orca Bio, a late-stage biotechnology company revolutionizing blood cancer treatment, as their Director of Clinical Data Management. Lead the data management function, ensuring data integrity across all clinical programs. This role demands strategic leadership and operational expertise to deliver high-quality clinical data solutions. You will design and implement clinical data strategies, lead the data management team, and ensure compliance with regulations. The position requires a strong background in clinical data management, leadership experience, and expertise in relevant systems and standards. Orca Bio offers a competitive salary, pre-IPO equity, comprehensive benefits, and a dynamic work environment.

Requirements

• BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience; advanced degree preferred
• 10+ years of progressive experience in clinical data management, with at least 5 years in leadership
• Comprehensive knowledge of clinical data management processes, systems, and regulatory requirements
• Proven experience with EDC systems (Zelta EDC preferred) and medical coding dictionaries
• Strong understanding of CDISC standards (CDASH, SDTM) and their implementation
• Track record of successfully building and leading data management teams
• Experience interacting with regulatory agencies regarding data management approaches
• Strategic thinker who can translate business objectives into actionable data strategies
• Strong interpersonal skills, including verbal and written communication, are essential
• Decisive problem-solver who can navigate complex challenges
• Collaborative partner who builds effective relationships across functions
• Flexibility in responding to change or business needs; desire to improve upon established processes
• Passionate about improving patient outcomes through rigorous clinical data practices

Responsibilities

• Design and implement comprehensive clinical data strategies aligned with Orca Bio's development objectives
• Lead data management team in all aspects of clinical data management from study startup through database lock for multiple concurrent studies
• Establish robust data collection, cleaning, and validation processes that ensure data integrity
• Direct database design, build, and maintenance activities with a focus on quality and efficiency
• Oversee query management, data reconciliation, and database lock procedures
• Develop and implement data quality management systems that ensure accuracy and reliability
• Establish data standards and processes based on CDASH/SDTM and other industry standards
• Ensure compliance with ICH guidelines, 21 CFR Part 11, and other relevant regulations
• Author and maintain SOPs and work instructions for clinical data management
• Implement risk-based quality management approaches to data oversight
• Mentor and develop a high-performing clinical data management team
• Provide direction, guidance, and quality oversight to team members, including consultants and vendors to achieve corporate goals and milestones
• Establish clear roles, responsibilities, and career development paths
• Partner with Biostatistics, Clinical Operations, Regulatory Affairs, and Medical Affairs
• Cultivate a culture of excellence, innovation, and continuous improvement
• Represent data management in interactions with regulatory agencies and external partners
• Manage relationships with data management vendors
• Manage departmental resources, timelines, budget, and performance metrics
• Provide leadership in recruiting, training, and retaining top talent

Preferred Qualifications

• Background in programming or technical data systems preferred
• Entrepreneurial mindset; thrives in a fast-paced, evolving environment

Benefits

• Pre-IPO equity
• Medical, dental, and vision benefits
• Flexible PTO
• 401(k) plan
• Life and accidental death and disability coverage
• Parental leave benefits
• Free daily lunches and snacks at our on-site locations