Clinical Data Manager - Lead Trial Data & Submissions

ICON Clinical Research; United States; On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plans

Employee Assistance Programme

Flexible benefits

Job summary

A leading clinical research organization is seeking a Clinical Data Manager to oversee data management activities, ensuring compliance and quality delivery in clinical trials. The ideal candidate should have a BS/BA in a health-related field and significant experience in data management or drug development. This role includes responsibilities like managing data quality, working closely with stakeholders, and ensuring adherence to regulations for successful study outcomes.

Qualifications

• 4+ years in data management or drug development.
• Strong knowledge of data management and regulatory practices.
• Experience in managing large programs and compliance with GXP.

Responsibilities

• Manage clinical trial data collection setup and oversee data review activities.
• Ensure milestones and deliverables are met with high quality.
• Participate in submission preparedness and represent the function during inspections.

Skills

Data Management Best Practices

Clinical Trial Documents

FDA & ICH Regulations

Education

BS/BA in health-related, life sciences, or technology fields

Job description

A leading clinical research organization is seeking a Clinical Data Manager to oversee data management activities, ensuring compliance and quality delivery in clinical trials. The ideal candidate should have a BS/BA in a health-related field and significant experience in data management or drug development. This role includes responsibilities like managing data quality, working closely with stakeholders, and ensuring adherence to regulations for successful study outcomes.