Clinical Data Manager Lead

CIMS Global is a next-generation Contract Research Organization (CRO) focused on advancing clinical research through innovative data science, technology, automation, and artificial intelligence. Our mission is to reshape the future of clinical trials by developing and implementing intelligent solutions that streamline processes, improve efficiency, and accelerate drug development.

We provide high-quality clinical data management, biostatistics, statistical programming, and advanced technology solutions designed to enhance every stage of the clinical trial lifecycle. By combining deep domain expertise with cutting-edge platforms and AI-enabled capabilities, CIMS helps sponsors improve the quality, speed, transparency, and reliability of clinical trial data acquisition, management, analysis, and regulatory submissions.

Our integrated approach empowers pharmaceutical, biotechnology, and medical device companies to make better decisions faster, reduce operational complexity, and bring innovative therapies to patients more efficiently.

• Company location: 285 Davidson Ave., Ste 504, Somerset, NJ 08873.
• website: www.cims-global.com
• Contact: [email protected]/[email protected]

• Role Description: the Director of Clinical Data Management (CDM) is responsible for providing strategic, operational, and technical leadership for all clinical data management activities across the organization. The Director oversees the planning, execution, and delivery of data management services to ensure high-quality, compliant, and timely clinical trial data supporting regulatory submissions and business objectives.
• This role is responsible for building and leading a high-performing data management organization, establishing standards and best practices, driving innovation and operational excellence, and ensuring successful execution of clinical programs across all phases of development. The Director serves as a key member of the leadership team and collaborates closely with tech development team, Biostatistics, Statistical Programming, Medical Writing, Quality Assurance, Information Technology, and external partners.

If you are passionate about working with a team that is developing and implementing some of the most advanced technologies in clinical trial workflows, this could be an ideal opportunity for you.

• Strategic Leadership
• Develop and execute the organization's clinical data management strategy aligned with corporate and clinical development objectives.
• Establish departmental goals, performance metrics, resource planning, and operational priorities.
• Drive continuous improvement initiatives to enhance quality, efficiency, scalability, and compliance.
• Evaluate and implement innovative technologies, including AI-enabled data review, risk-based monitoring, automation, and advanced analytics.
• Support organizational initiatives related to digital transformation and data governance.
• Operational Oversight
• Provide oversight of all clinical data management activities across multiple studies and programs.
• Ensure consistent implementation of data management standards, processes, and methodologies.
• Monitor study performance, quality metrics, timelines, and resource utilization.
• Identify and mitigate operational risks impacting study execution and data quality.
• Ensure timely database lock, analysis readiness, and submission deliverables.
• Leadership and Talent Development
• Lead, mentor, and develop Data Management Managers, Lead Data Managers, and Data Management staff.
• Establish workforce planning, hiring, training, and succession planning strategies.
• Foster a culture of accountability, collaboration, innovation, and continuous learning.
• Conduct performance evaluations and support career development initiatives.
• Client and Stakeholder Management
• Serve as the executive sponsor for key clients and strategic partnerships.
• Participate in business development activities, capability presentations, proposals, and bid defenses.
• Build and maintain strong relationships with sponsors, partners, and vendors.
• Provide strategic consultation on data management approaches and technologies.
• Quality and Compliance
• Ensure compliance with:
• ICH-GCP
• FDA regulations
• EMA and global regulatory requirements
• 21 CFR Part 11
• Company SOPs and quality systems
• Oversee audit and inspection readiness activities.
• Support regulatory inspections and sponsor audits.
• Ensure implementation and maintenance of quality management processes.
• Technology and Innovation
• Provide leadership in the selection, implementation, and optimization of:
• Electronic Data Capture (EDC) systems
• eCOA/ePRO platforms
• Clinical data repositories
• Data visualization tools
• AI-enabled and automated data review solutions
• Drive adoption of emerging technologies that improve clinical data quality and operational efficiency.
• Collaborate with IT and technology teams to establish scalable and compliant data management infrastructure.
• Financial and Resource Management
• Develop and manage departmental budgets.
• Forecast resource requirements and capacity needs.
• Monitor project profitability and utilization metrics.
• Support strategic planning and business growth initiatives.
• Qualifications
• Education
• Bachelor's degree in Life Sciences, Statistics, Computer Science, Health Informatics, Public Health, or related field.
• Master's degree preferred.
• Experience
• Minimum 10+ years of clinical data management experience in the pharmaceutical, biotechnology, or CRO industry.
• Minimum 5 years of leadership experience managing teams and clinical programs in CRO settings.
• Demonstrated success leading data management operations across multiple studies and therapeutic areas.
• Experience supporting global clinical development programs and regulatory submissions.
• Technical Expertise
• Extensive knowledge of clinical trial processes and data management methodologies.
• Advanced knowledge of:
• Medidata Rave, Veeva EDC, or equivalent systems
• CDISC standards (CDASH, SDTM)
• Data review and reconciliation processes
• Risk-based quality management
• Clinical trial technologies and integrations
• Familiarity with statistical analysis workflows and regulatory submission requirements.
• Regulatory Knowledge
• Expert knowledge of:
• ICH-GCP
• FDA and EMA regulations
• 21 CFR Part 11
• GxP requirements
• Clinical data standards and submission practices
• Leadership Competencies
• Strategic thinking and vision
• Executive presence and influence
• Organizational leadership
• Financial and business acumen
• Change management
• Talent development and coaching
• Client relationship management
• Strong communication and presentation skills
• Preferred Qualifications
• Experience in oncology, rare disease, cell and gene therapy, or other complex therapeutic areas.
• Experience within both sponsor and CRO environments.
• Experience implementing AI-enabled data management solutions and advanced analytics platforms.
• Familiarity with centralized monitoring, dynamic data review, and real-time clinical trial initiatives.
• Experience supporting NDA, BLA, MAA, and other global regulatory submissions.