Director, Clinical Data Management

This is a fully remote position, open to applicants in New Jersey.

📋 Description

• Create and oversee clinical data operations to ensure the development of complete, valid, safe, and secure databases that comply with corporate and regulatory standards.

• Formulate and manage budgets and resource plans for clinical data management.

• Evaluate and oversee the utilization of resources and budgets.

• Meet divisional goals within the established budget.

• Manage client project portfolios alongside other corporate leaders.

• Foster strong relationships with clients.

• Support project proposals for new initiatives.

• Guarantee the timely availability, completeness, validity, and efficiency of clinical data capture instruments and databases.

• Plan and oversee the integration of CRF design, database definition and administration, data entry, data management, storage, quality control, and quality assurance.

• Combine Clinical Data Management with Quality Assurance and Compliance, Project Management, Clinical Operations, Biostatistics, Statistical Programming, and Medical Writing.

• Conduct competitive benchmarking of clinical data operations.

• Develop and uphold data management guidelines and procedures consistent with industry best practices.

• Research, establish, and implement innovative systems, standards, and procedures.

• Recruit, train, inspire, and develop team members.

• Conduct annual and semi-annual performance evaluations.

• Organize, execute, and supervise staff training and professional development.

• Plan, manage, and regulate resources to achieve unit and corporate missions, goals, and policies.

⛳️ Requirements

• A Master’s degree in Computer Science, Biostatistics, Mathematics, or Life Sciences.

• Lower academic qualifications may be accepted with demonstrated abilities and requisite expertise for the role.

• Minimum of 15 years of experience in Clinical Data Management.

• At least 3 years of experience in a line management role.

• Extensive knowledge of systems, programs, and operations necessary for collecting, storing, performing quality control and quality assurance, and processing clinical data.

• Familiarity with international standards, including 21 CFR Part 11 and ICH guidelines.

• Proven experience in leading a team and exceptional people management skills.

• Ability to successfully interact and communicate effectively with individuals at all organizational levels.

• Experience in designing and implementing Standard Operating Procedures for Clinical Data Management.

• Preferred experience in client relationship management and future business development.

• Strong analytical and creative problem-solving abilities.

• Excellent skills in managing client relationships.

• Dedication to process enhancement.

• Capability to develop and implement strategic operations and processes.

• Technical proficiency and experience managing high-profile projects.

• Strong written and oral communication skills.

• Experience in leading or participating in the evaluation and implementation of new systems, processes, and standards.

• Experience in guiding the development and implementation of new standards and procedures.

🏝️ Benefits

• Opportunity for remote work from a home-based office anywhere in the United States, in accordance with the Work from Home policy.

• Accommodations available for candidates participating in any phase of the recruitment and selection process, upon request.

• Equal opportunity employment and protections for veterans and individuals with disabilities.