Senior Clinical Data Analyst

Senior Clinical Data Analyst (Senior CDA) - United States (Home or Office Based)

As functional Lead for Clinical Risk Management, the Senior Clinical Data Analyst works as part of a global team and will be responsible for implementation of Central Monitoring on the assigned projects.

Role & Responsibility:

As Clinical Risk Management functional lead, the Clinical Data Analyst is responsible for set-up and implementation of Central Monitoring for one or more studies.

Additional responsibilities will include:

• Provide input to study risk assessment and propose appropriate and tailored risk indicators for central analysis, in line with holistic data monitoring model
• Create and own the Central Monitoring Plan
• Support set-up and testing of data analysis platform
• Review clinical study data to identify potential site performance and site organization issues
• Train and support the project teams about interpretation of Central Monitoring outputs and relevant decision making for study conduct
• Manage operational risk log for Clinical Risk Management activities
• Communicate effectively with the project team, CRAs, Project Managers, Clinical Trial Managers, DM Staff, Medical staff, Scientific Council to ensure adequate decisions are taken about the study monitoring strategy and effective resolution of site performance issues
• Oversee Clinical Risk Management project budget, scope of work, forecasting
• As a senior member, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes and adding value to our business and meeting client needs.
• Act as a mentor for CRM team members.

Experience & Qualifications:

The ideal candidate will have significant clinical research associate (CRA) or clinical data management experience.

• Bachelor's degree or local equivalent in a scientific discipline and/or appropriate experience
• Previous Central Monitoring Experience is required
• Knowledge of regulatory requirements respecting data quality and clinical trials conduct.
• Knowledge of risk based quality management framework and how central monitoring supports
• Must possess excellent oral communication skills and attentiveness to detail.
• Proven leadership skills and the ability to work independently to resolve study related issues
• Ability to work within a team environment and manage competing priorities in a changeable environment
• Knowledge of database technologies and processes.
• Ability to handle stressful situations and deadlines.
• Demonstrate ownership and accountability for achieving results.
• Excellent interpersonal skills required