Director – Clinical Data Management

Director – Clinical Data Management

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