Manager, Data Quality

This is a fully remote position, open to applicants in United States.

📋 Description

• Lead and mentor Data Coordinators by establishing expectations, assigning tasks, coaching performance, and enhancing team capabilities.

• Set priorities on a daily and weekly basis across designated studies and sites.

• Balance team workload with participant visits, sponsor deadlines, monitoring activities, and database milestones.

• Uphold quality control measures for source review, EDC/CRF transcription, reconciliation, and documentation.

• Analyze performance trends to ensure compliance with protocols, GCP, sponsor requirements, and Care Access procedures.

• Monitor open, aging, and high-risk queries while coordinating escalations with site teams, investigators, sponsors, CROs, and internal partners.

• Record decisions and follow-up actions in authorized systems.

• Define and oversee metrics related to site-level quality, timeliness, workload, and recurring issues.

• Standardize best practices, enhance workflows, and communicate performance trends and risks to leadership.

• Collaborate with Clinical Operations, Operational Compliance, site leadership, and study teams.

• Assist in the implementation of studies, tools, reports, and process modifications.

• Contribute to audit and inspection preparedness.

• Undertake related responsibilities and special projects.

⛳️ Requirements

• Strong comprehension of clinical research data workflows, including source documentation, EDC/CRF entry, query management, reconciliation, and documentation practices.

• Capability to lead and develop a remote team, establish accountability, and manage competing priorities.

• Proficient knowledge of GCP, protocol compliance, sponsor expectations, and quality management principles.

• Ability to analyze data, detect trends and risks, and spearhead practical process enhancements.

• Excellent written and verbal communication skills.

• Proficient in Microsoft Office and clinical research systems, including EDC platforms and quality management systems.

• High school diploma or GED is required.

• A minimum of five years of experience in clinical research, clinical data management, site coordination, or a related field is required.

• At least two years of experience in leading, coaching, or coordinating the work of others.

• Experience in reviewing, entering, reconciling, or maintaining structured data in electronic systems, spreadsheets, trackers, or databases.

• Familiarity with handling confidential or regulated information.

• Care Access is currently unable to sponsor work visas.

🏝️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays.

• 100% Employer paid medical, dental, and vision insurance plan options.

• Health Savings Account and Flexible Spending Accounts.

• Bi-weekly HSA employer contribution.

• Company paid Short-Term Disability and Long-Term Disability.

• 401(k) Retirement Plan, with Company Match.

• Occasional planned travel as part of the role.