Note: The job is a remote job and is open to candidates in USA. Shoulder Innovations is a medical device startup specializing in innovative shoulder replacement systems. The Clinical Data Associate will manage clinical data activities throughout the study lifecycle, including data review, query management, and data reconciliation, while maintaining Power BI dashboards to monitor study metrics and site performance.
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. Development experience is a plus
- 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
Skills
- 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
- Development experience with Power BI is a plus
- Power Query/M language experience is a plus
Benefits
- Great company culture
- Opportunities for professional growth
- Competitive wages
- Benefits
Company Overview