Care Access is hiring a
Pre-Screening Data Quality Manager

Summary

The Pre-Screening Data Quality Manager will oversee the data quality process for the Care Access Pre-screening Program, ensuring compliance with regulations and company SOPs. The role requires leadership qualities, project management experience, strong communication skills, and knowledge of federal regulations and good clinical practices (GCP).

Requirements

• 4-5 years of Clinical Research experience, CCRC Preferred
• Regulatory submission and Investigator Site File experience
• Strong knowledge of GCP-ICH requirements and data collection in a research setting
• Proficient in research terminology and medical (basic) terminology

Responsibilities

• Develop the data quality plan in coordination with the central compliance team, site network leadership, and pre-screening event leadership
• Work closely with site personnel to ensure the clinical data is accurate and complete
• Create training materials for the on-site data quality plan for the pre-screening training team
• Follow up with Site management to resolve queries promptly, ensuring quality data throughout the project
• Maintain a quality dashboard and report findings and trends to sites and leadership
• Adjust the on-site data quality plan where necessary based on data trends and assist in facilitating training/re-training as needed
• Operationalize and implement the pre-screening data quality process for the pre-screening program
• Regularly review and assess the process for potential improvements in efficiency and accuracy
• Maintain a call schedule for overseeing data quality at all sites active on a certain pre-screening project
• Ensure all Care Access sites are aligned in their processes, company SOPs, and program-specific protocols regarding data quality checks, escalating where appropriate

Benefits

• PTO/vacation days, sick days, holidays
• 100% paid medical, dental, and vision Insurance. 75% for dependents
• HSA plan
• Short-term disability, long-term disability, and life Insurance
• Culture of growth and equality
• 401k retirement plan