Director, Clinical Data Management

Ora

3d

About The Position

The Director, Clinical Data Management oversees all aspects of data management operations, including staffing and staff development, project resource planning and loading, project management, sponsor support, and quality execution and output. The role applies extensive technical expertise and professional experience to lead data management and clinical programming staff and develop solutions to operational problems. The Director keeps leadership informed of project status and analyzes performance metrics for trends, root causes, and corrective actions.

The position provides strategic and operational leadership to support the growth and efficiency of Ora’s clinical data management function. It also contributes to business development, client support, budgeting, process improvement, regulatory compliance, and cross-functional collaboration.

Requirements

• Bachelor’s degree in an applied or life science and at least 12 years of clinical-trial experience, including at least 10 years in data management, or equivalent education and work experience.
• Extensive clinical data management experience, preferably in a CRO environment.
• A record of successfully establishing, directing, and overseeing data management operations in a dynamic environment, including budgeting and forecasting, individual and team leadership, process management, and project management.
• Expert knowledge and understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11.
• CDISC CDASH/SDTM training and experience.
• Ability to set goals, create structure, and maintain a focused, collaborative approach to timely, high-quality work.
• Agile and positive approach to communication and collaboration, with authenticity, transparency, resilience, empathy, and a growth mindset.
• Clear and direct communication, feedback, and conflict-resolution skills.

Nice To Haves

• Advanced degree.
• Direct supervisory experience.
• Experience in ophthalmology.
• Programming and medical coding skills, including coding adverse events, medical history, and medical therapies.
• EDC experience with Oracle Clinical Life Sciences Suite and iMedNet.

Responsibilities

• Oversee day-to-day data management operations.
• Lead the allocated team, manage resources, and support the growth of Ora’s clinical data management function and individual team members.
• Serve as a clinical data management subject matter expert in cross-functional initiatives and lead customer communication and collaboration.
• Support business development through capabilities presentations to prospective and current clients.
• Manage department and clinical study budgets to achieve or exceed targets.
• Liaise with internal and external cross-functional teams, sponsors, and vendors.
• Participate in proposal and contract writing and negotiation.
• Review, write, and update standard operating procedures, work instructions, forms, and templates to improve efficiency in clinical data management processes.
• Continuously improve data management operations to reduce costs and timelines while improving quality.
• Manage clinical data management team resourcing and workload.
• Develop, maintain, analyze, and report departmental performance metrics and key performance indicators.
• Develop and conduct in-house training and development.
• Adhere to Ora’s quality management system and the systems and processes required for data integrity, business ethics, and regulatory compliance.
• Demonstrate Ora’s values of prioritizing kindness, operational excellence, cultivating joy, and scientific rigor.

What This Job Offers

• Job Type: Full-time
• Career Level: Director