What are the responsibilities and job description for the Clinical Data Management Director position at Vetted Solutions?
Role Overview
The Director, Clinical Data Management is responsible for overseeing all activities related to planning, executing, and delivering high-quality, reliable clinical trial data. They ensure consistency across projects, support data management excellence, and contribute to strategic departmental goals.
Key Responsibilities
The Director, Clinical Data Management is responsible for overseeing all activities related to planning, executing, and delivering high-quality, reliable clinical trial data. They ensure consistency across projects, support data management excellence, and contribute to strategic departmental goals.
Key Responsibilities
- Drive the strategic direction of Clinical Data Management and support development of standards, policies, and processes.
- Oversee outsourcing activities, vendor qualification, and vendor performance to maintain high quality standards.
- Lead process improvements, audits, inspections, and ensure compliance with GCP and regulatory requirements.
- Manage and develop Clinical Data Management staff, supporting training and competency growth.
- Participate in cross-functional initiatives, ensuring effective collaboration and data quality.
- Support system development, risk assessments, and oversee data validation, integrity, and reporting.
- Act as a key member of Partnership Oversight Committees to foster vendor relationships and operational excellence.
- Provide project-level oversight, ensuring data management activities align with trial goals and regulatory standards.
- Strong expertise in clinical data management, ICH-GCP, and regulatory guidelines.
- Proven experience in vendor management, process development, and audit readiness.
- Leadership skills in managing teams, driving strategic initiatives, and fostering continuous improvement.
- Technical proficiency in EDC systems, data analysis tools, and MS Office.
- Excellent communication, problem-solving, and decision-making abilities.
- Ability to interpret complex clinical data and implement innovative data management solutions.
- Strategically lead and develop the Clinical Data Management team and processes.
- Ensure high-quality data collection, cleaning, and database lock activities.
- Oversee vendor relationships and compliance activities, including audits and inspections.
- Support system enhancements and process optimizations to improve efficiency.
- Contribute to cross-functional projects and organizational goals.
- Manage project-specific data activities, including oversight of Data Management Plans, workflows, and documentation.