Clinical Data Management Director (CDM Director)

Job Description

As the Clinical Data Management Director (CDM Director), you will lead the entire data management process for clinical trials. This role requires extensive experience in clinical data management, as well as strong leadership and project management skills. You will collaborate closely with various teams to ensure data accuracy, compliance, and the implementation of quality control measures.

Responsibilities

• Direct the development of clinical data management plans to guide data operations across studies.
• Ensure the accuracy, completeness, and consistency of clinical trial data.
• Lead the clinical data management team to achieve project milestones within specified timelines.
• Collaborate with statisticians, clinical researchers, and operations staff to facilitate data-driven decisions.
• Establish and enforce standard operating procedures for clinical data management activities.
• Monitor and document the progress of data management activities and address any issues promptly.
• Engage with regulatory bodies during audits and inspections, providing documentation and compliance evidence.
• Support the electronic data capture system, ensuring optimal utilization and troubleshooting as needed.
• Conduct training sessions for new staff on data management processes and tools.
• Maintain awareness of advancements in clinical data management and implement relevant technologies.

Requirements

Education

• Master's degree in a relevant field such as life sciences, data science, or statistics.

Experience

• 10+ years in clinical data management, including experience in leading data management in clinical trials.

Technical Skills

• Data Visualization Tools
• Electronic Data Capture Systems

Soft Skills

• Team Collaboration
• Problem-Solving

Certifications

• Project Management Professional (PMP)

Languages

• English: Fluent

Advantageous

• Experience with SAS Programming: Ability to perform statistical analysis using SAS tools.
• Experience in a CRO Setting: Prior experience working in a Contract Research Organisation (CRO).

Benefits

• Comprehensive health insurance plan with dental and optical cover.
• Generous paid time off, including public holidays.
• Retirement plan options with employer contributions.
• Employee recognition programs to reward outstanding performance.

Company Culture

• Supportive Environment: Our management team supports employee growth through mentorship and professional development opportunities.
• Work-Life Balance: We prioritize the well-being of our employees, offering flexibility and understanding in work arrangements.
• Innovation: We encourage an innovative mindset, welcoming new ideas and approaches to enhance our operations.