Director, Clinical Data Management

🕒 October 19

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

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Ora

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏭 Manufacturing

💼 Consulting

📦 Logistics

Manufacturing • Consulting • Logistics

Ora is the world's leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia, and Asia. For over 45 years, Ora has helped clients earn more than 85 product approvals, supporting a wide array of organizations from start-ups to global pharmaceutical and device companies. Their offerings include pre-clinical and clinical models, unique methodologies, integrated clinical data solutions, and global regulatory strategies, all refined through thousands of global projects. Ora boasts an extensive and experienced team of ophthalmic experts, R&D professionals, and management executives to maximize the value of new product initiatives.

📋 Description

• Oversee day-to-day clinical data management operations • Lead allocated teams and manage resources to support growth of Ora’s clinical data management function and team members • Serve as a clinical data management subject matter expert in cross-functional initiatives • Perform expert-level customer communication and collaboration • Support business development capability presentations for prospective and current clients • Manage department and clinical study budgets to achieve or beat 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 • Continuously improve data management operations to reduce costs and timelines while improving quality • Manage CDM team resourcing and workload • Develop, maintain, analyze and report departmental performance metrics and KPIs • Develop and conduct in-house training and development • Adhere to Ora’s quality management system, data integrity, business ethics and regulatory requirements • Keep leadership informed of data management project status • Participate in business development and strategic planning

🎯 Requirements

• Bachelor’s degree in applied or life science and minimum of twelve (12) years of experience in clinical trials, with at least ten (10) years in data management, or equivalent education and work experience • Advanced degree and direct supervisory experience preferred • Extensive experience in clinical data management, preferably within a CRO environment • Record of accomplishment establishing, directing and overseeing data management operations in a dynamic environment • Experience with budgeting and forecasting, individual and team leadership, process management and project management • Expert knowledge of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11 • CDISC CDASH/SDTM training and experience • Experience in ophthalmology is a plus • Programming and medical coding skills are a plus • EDC experience with Oracle Clinical Life Sciences Suite and iMedNet is a plus • Ability to set goals, create structure and maintain a focused and collaborative approach to timely, high-quality work • Ability to communicate and collaborate using authenticity, transparency, resilience and empathy

🏖️ Benefits

• Fair, equitable compensation regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status • Equal employment opportunity as an Affirmative Action and Equal Opportunity Employer

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