Clinical Data Associate

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

📋 Description

• Execute thorough data management activities, encompassing data review, query generation, and resolution.

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

• Conduct ongoing data reconciliation across various data streams, such as EDC, imaging, and third-party vendors.

• Assess discrepancy/edit check outputs and validation listings in accordance with the Data Management Plan (DMP).

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

• Oversee eCRF freeze/lock procedures.

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

• Act as a skilled daily user of the EDC system (e.g., Castor EDC, Rave, or similar).

• Create reports directly from the EDC system to monitor data cleaning progress and outstanding queries.

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

• Convert data management metrics (such as missing data, outstanding queries, and protocol deviations) into clear visual reports for internal stakeholders.

⛳️ 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.

• Practical experience with EDC systems is required (Castor EDC, Rave, Inform, or similar).

• Proven ability to manage reports and dashboards in Power BI (experience with Power Query/M language is a plus).

• Familiarity with current industry standards (e.g., GCP, ICH, CDISC/CDASH).

• Proficiency in Microsoft Office (Excel, Word); strong skills in Excel are essential.

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

🏝️ Benefits

• Excellent company culture.

• Opportunities for professional advancement.

• Competitive salary.

• Comprehensive benefits.