Clinical Data Associate

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

📋 Description

• Execute thorough data management activities, including data assessment, query creation, and query resolution.

• Provide support throughout all phases of the study: Start-up, Execution, Database Lock, and Close-out.

• Conduct continuous data reconciliation across various data streams, encompassing EDC, imaging, and third-party vendors.

• Review outputs of discrepancies/edit checks and validation listings in accordance with the Data Management Plan.

• Address resolved queries and initiate re-queries where necessary.

• Acquire and reconcile imaging data.

• Oversee eCRF freeze/lock processes.

• Organize documentation within the Trial Master File.

• Assist in study closeout and archiving processes, including quality control of subject/site CRFs.

• Act as a skilled day-to-day user of the EDC system, demonstrating awareness of form/field configuration, user access, and data export.

• Produce EDC reports to monitor data cleaning progress and outstanding queries.

• Conduct quality reviews and internal quality control checks for data management.

• Facilitate EDC-related testing during study build and amendments.

• Sustain Power BI dashboards and reports that track data cleaning status, query aging, site-level data quality metrics, and monitoring visit findings.

• Convert data management metrics into clear visual reports for internal stakeholders.

• Manage and resolve issues with Power Query/Power BI data pipelines.

• Ensure the accuracy of dashboard data through reconciliation with EDC source data.

• Participate in study-related meetings and teleconferences.

• Monitor project progress and provide regular status/metric reports.

• Aid in determining the achievement of milestones according to study timelines.

• Engage in the finalization and transfer of the clinical database and associated documents to the sponsor.

• Join internal meetings and participate in internal/external audits as necessary.

• Maintain familiarity with contract scope and study-specific Clinical Data Management Plans.

⛳️ Requirements

• Bachelor's degree in a health, science, or related field, or equivalent experience in clinical research.

• Experience as a clinical data associate/manager at a CRO, pharmaceutical, medical device, or biotech company.

• Required hands-on experience with EDC systems (e.g., Castor EDC, Rave, Inform, or similar).

• Proven ability to manage reports and dashboards in Power BI.

• Familiarity with Power Query/M language is an advantage.

• Understanding of current industry standards (such as GCP, ICH, CDISC/CDASH).

• Proficient in Microsoft Office applications (Excel, Word).

• Strong skills in Excel are essential.

• Experience collaborating within cross-functional, multi-site clinical trial teams.

🏝️ Benefits

• Positive company culture.

• Opportunities for professional development.

• Competitive salary.

• Comprehensive benefits.