Clinical Data Associate

Job not on LinkedIn

🔥 20 hours ago

🚗 Michigan – Remote

info

💵 $70k - $85k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

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Logo of Shoulder Innovations

Shoulder Innovations

11 - 50 employees

The simplicity of our design--born out of our extensive experience--comes down to the basic notion that traditional fixation techniques aren't strong enough and don't last.

📋 Description

• Perform comprehensive data management tasks including data review, query generation, and query resolution • Support all study phases: Start-up, Execution, Database Lock, and Close-out • Perform ongoing data reconciliation across all data streams (e.g., EDC, imaging, third-party vendors) • Review discrepancy/edit check output and validation listings per the Data Management Plan (DMP) • Resolve answered queries and re-query where appropriate • Manage eCRF freeze/lock activities • Support study closeout and archiving activities, including QC of subject/site CRFs • Serve as a proficient day-to-day user of the EDC system (e.g., Castor EDC, Rave, or equivalent) • Generate reports directly from the EDC system to track data cleaning progress and outstanding queries • Maintain Power BI dashboards and reports to track data cleaning status, query aging, site-level data quality metrics, and monitoring visit findings • Translate data management metrics (e.g., missing data, outstanding queries, protocol deviations) into clear visual reports for internal stakeholders

🎯 Requirements

• Bachelor's degree in a health, science, or related discipline, or equivalent experience in clinical research • Clinical data associate/management experience at a CRO, pharma, medical device, or biotech company • Hands-on experience with EDC systems required (Castor EDC, Rave, Inform, or equivalent) • Demonstrated proficiency managing reports/dashboards in Power BI (Power Query/M language experience a plus) • Knowledge of current industry standards (e.g., GCP, ICH, CDISC/CDASH) • Proficiency with Microsoft Office (Excel, Word); strong Excel skills required • Experience working in cross-functional, multi-site clinical trial teams

🏖️ Benefits

• Great company culture • Opportunities for professional growth • Competitive wages • Benefits

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