Clinical Data Associate

Shoulder Innovations•Grand Rapids, MI

About The Position

Shoulder Innovations is a medical device startup that is revolutionizing shoulder replacements. Led by a seasoned team with over a century of orthopedic expertise, we’ve developed a disruptive shoulder replacement system and secured substantial funding to drive rapid growth. (NYSE: SI). We’re seeking entrepreneurial talent to join us on this exciting journey. Our culture is built on: People First : Authentically human. One Team : Empowered and aligned. Innovation : Bold, creative, and daring. Growth Mindset : Always curious. Ready to make an impact in orthopedics? Let’s grow together! We are seeking a Clinical Data Associate who is responsible for clinical data management activities across study lifecycle; from start-up through database lock and closeout. This role includes day-to-day data review, query management, and data reconciliation within the Electronic Data Capture (EDC) system, and maintains Power BI dashboards to monitor data cleaning progress, site performance, and study metrics.

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
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

Nice To Haves

Development experience is a plus.
Power Query/M language experience a plus

Responsibilities

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
Receive and reconcile imaging data
Manage eCRF freeze/lock activities
File documentation in the Trial Master File (TMF)
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), including form/field configuration awareness, user access, and data export
Generate reports directly from the EDC system to track data cleaning progress and outstanding queries
Perform DM quality review and other internal QC checks per applicable EDC systems
Support EDC-related testing (edit checks, validation rules, user acceptance testing) during study build and amendments
Maintains 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
Maintain and troubleshoot existing Power Query/Power BI data pipelines feeding from EDC exports and other source systems
Ensure dashboard data accuracy through regular 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