Cdm Manager

Greetings!

Job Title: Associate Manager Clinical Data Management

Experience: 6+ Years

Location: Remote

Job Summary

We are seeking an experienced Associate Manager Clinical Data Management to oversee and manage clinical data management activities across drug development programs. The ideal candidate will have strong expertise in clinical data management processes, regulatory compliance, project management, and cross-functional collaboration. This role is responsible for ensuring high-quality clinical data, timely study deliverables, inspection readiness, and continuous process improvements.

Key Responsibilities

• Lead and coordinate clinical data management activities across multiple clinical studies and development programs.
• Ensure submission readiness, archival, and inspection readiness of all Data Management Trial Master File (TMF) documents.
• Manage data management timelines, budgets, and external vendor activities to ensure on-time, high-quality deliverables.
• Collaborate with Clinical Operations, Biostatistics, Statistical Programming, Therapeutic Area teams, and external partners to ensure seamless execution of data management activities.
• Monitor study progress and ensure achievement of key data management milestones.
• Ensure data quality, integrity, and compliance with organizational SOPs, GCP, FDA, and ICH guidelines.
• Develop, monitor, and report key performance metrics (KPIs) for data management activities.
• Drive continuous improvement initiatives by identifying opportunities to enhance processes, tools, and operational efficiency.
• Champion the adoption of new technologies and industry best practices within Clinical Data Management.
• Ensure compliance with corporate training requirements, GxP standards, and applicable regulatory requirements.
• Support audits, inspections, and regulatory submissions as required.

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