Director, Clinical Data Management

This is a fully remote position, open to applicants in United States.

📋 Description

• Manage daily operations related to clinical data management.

• Lead assigned teams and oversee resources to enhance the growth of Ora’s clinical data management function and its team members.

• Act as a subject matter expert in clinical data management for cross-functional initiatives.

• Engage in expert-level communication and collaboration with customers.

• Assist in business development presentations for both prospective and current clients.

• Oversee department and clinical study budgets to meet or exceed targets.

• Coordinate with internal and external cross-functional teams, sponsors, and vendors.

• Take part in proposal and contract drafting and negotiation.

• Review, compose, and revise standard operating procedures, work instructions, forms, and templates.

• Continuously enhance data management operations to lower costs and timelines while boosting quality.

• Manage the resourcing and workload of the CDM team.

• Develop, maintain, analyze, and report on departmental performance metrics and KPIs.

• Create and deliver in-house training and development programs.

• Comply with Ora’s quality management system, data integrity standards, business ethics, and regulatory requirements.

• Keep leadership updated on the status of data management projects.

• Engage in business development and strategic planning activities.

⛳️ Requirements

• Bachelor’s degree in applied or life sciences with a minimum of twelve (12) years of experience in clinical trials, including at least ten (10) years in data management, or equivalent education and experience.

• An advanced degree and direct supervisory experience are preferred.

• Significant experience in clinical data management, ideally within a CRO environment.

• Proven track record in establishing, directing, and overseeing data management operations in a fast-paced setting.

• Experience in budgeting and forecasting, individual and team leadership, process management, and project management.

• Expert understanding of ICH Guidelines for Good Clinical Practice and Title 21 of the Code of Federal Regulations Part 11.

• Training and experience with CDISC CDASH/SDTM.

• Experience in ophthalmology is an advantage.

• Skills in programming and medical coding are beneficial.

• Familiarity with EDC systems, particularly Oracle Clinical Life Sciences Suite and iMedNet, is a plus.

• Capability to set objectives, create structure, and maintain a focused and collaborative approach to deliver timely, high-quality work.

• Strong communication and collaboration abilities characterized by authenticity, transparency, resilience, and empathy.

🏝️ Benefits

• Fair and equitable compensation irrespective of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

• Commitment to equal employment opportunity as an Affirmative Action and Equal Opportunity Employer.