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Clinical Data Associate

Job not on LinkedIn

🔥 5 minutes ago

🚗 Michigan – Remote

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đź’µ $70k - $85k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

đź‘» Ghost score 0%

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Logo of Shoulder Innovations

Shoulder Innovations

11 - 50 employees

🏭 Manufacturing

🏥 Healthcare

đź’Š Pharmaceuticals

Manufacturing • Healthcare • Pharmaceuticals

Shoulder Innovations is a medical device company that specializes in innovative solutions for shoulder replacement, most notably through its core technology, the InSet™ Glenoid. The company focuses on enhancing the longevity and effectiveness of glenoid fixation techniques, recognizing that traditional methods often fall short. Their approach aims to revolutionize shoulder arthroplasty and significantly improve patient outcomes.

đź“‹ 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, including EDC, imaging, and third-party vendors • Review discrepancy/edit check output and validation listings per the Data Management Plan • Resolve answered queries and re-query where appropriate • Receive and reconcile imaging data • Manage eCRF freeze/lock activities • File documentation in the Trial Master File • Support study closeout and archiving activities, including QC of subject/site CRFs • Serve as a proficient day-to-day user of the EDC system, including form/field configuration awareness, user access, and data export • Generate EDC reports to track data cleaning progress and outstanding queries • Perform DM quality review and internal QC checks • Support EDC-related testing during study build and amendments • Maintain Power BI dashboards and reports tracking data cleaning status, query aging, site-level data quality metrics, and monitoring visit findings • Translate data management metrics into clear visual reports for internal stakeholders • Maintain and troubleshoot Power Query/Power BI data pipelines • Ensure dashboard data accuracy through reconciliation against EDC source data • Attend study-related meetings and teleconferences • Track project progress and issue periodic status/metric reports • Assist in identifying achievement of milestones per study timelines • Participate in finalization and transfer of the clinical database and related documents to the sponsor • Participate in internal meetings and internal/external audits as required • Maintain awareness of contract scope and study-specific Clinical Data Management Plans

🎯 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 is 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

Apply Now

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