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Shoulder Innovations is a medical device startup revolutionizing shoulder replacements, backed by substantial funding and led by a team with over a century of orthopedic expertise (NYSE: SI). The company is seeking a Clinical Data Associate to manage clinical data across the full study lifecycle—from start-up through database lock and closeout.
In this role, you will own day-to-day data management activities including comprehensive data review, query generation and resolution, and data reconciliation across multiple data streams (EDC, imaging, third-party vendors). You'll perform ongoing validation checks per the Data Management Plan, manage eCRF freeze/lock activities, file documentation in the Trial Master File, and support study closeout and archiving with quality control of subject and site case report forms.
You will serve as a proficient user of Electronic Data Capture (EDC) systems such as Castor EDC, Rave, or equivalent, handling form/field configuration, user access management, and data exports. You'll generate reports directly from the EDC system to track data cleaning progress and outstanding queries, perform quality review and internal QC checks, and support EDC-related testing including edit checks, validation rules, and user acceptance testing during study build and amendments.
A key responsibility is maintaining Power BI dashboards and reports to track data cleaning status, query aging, site-level data quality metrics, and monitoring visit findings. You'll translate data management metrics (missing data, outstanding queries, protocol deviations) into clear visual reports for internal stakeholders, maintain and troubleshoot Power Query/Power BI data pipelines, and ensure dashboard accuracy through regular reconciliation against EDC source data.
You will attend study-related meetings, track project progress, issue periodic status and metric reports, assist in identifying milestone achievement, and participate in finalizing and transferring the clinical database to the sponsor. You'll also participate in internal meetings and audits as required, and maintain awareness of contract scope and study-specific Clinical Data Management Plans.
The company culture emphasizes People First (authentically human), One Team (empowered and aligned), Innovation (bold, creative, daring), and Growth Mindset (always curious).
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 (GCP, ICH, CDISC/CDASH)
- Proficiency with Microsoft Office (Excel, Word); strong Excel skills required
- Experience working in cross-functional, multi-site clinical trial teams
