Clinical Data Analyst II

We are looking for Clinical Data Analyst II (CDAII) to join our team in Mexico. CDA will perform clinical data validation activities independently, supports data validation and documentation tasks. Additionally, it will adhere to quality standards, SOPs, ICH-GCP, and regulatory requirements. May mentor junior CDAs and lead specific data validation processes.

Key Accountabilities:

• Data Validation: Lead cleaning, review, and reconciliation activities.
• Documentation: Set up and maintain DM documents per SOPs and guidelines. Study Start-Up: Perform UAT on database setups, review protocols.
• Quality Management: Ensure compliance with SOPs and ICH/GCP guidelines. Training: Maintain compliance, provide on-the-job training, mentor others.

Skills:

• Problem-solving and logical reasoning.
• Attention to detail and commitment to quality.
• Time management and prioritization.
• Teamwork and coordination.
• Effective communication.
• Adaptability and quick learning.

Knowledge and Experience:

• Strong technical aptitude in Microsoft Office.
• Understanding of DM processes and ICH-GCP guidelines.
• Knowledge of Clinical Data Management Systems.
• Familiarity with medical terminology and coding dictionaries.
• Understanding of DM operational processes.
• Basic knowledge of SAS and CDISC standards.