Clinical Data Associate — EDC & Power BI Expert

Shoulder Innovations LLC; Grand Rapids (MI); On-site; USD 65,000 - 90,000; Full time

Job summary

Shoulder Innovations LLC in Grand Rapids, MI is seeking a Clinical Data Associate to manage data across the study lifecycle within our medical device programs. You will work with EDC systems, ensure data quality, and support dashboards in Power BI to monitor data cleaning, site performance, and study metrics.

You will collaborate with cross-functional teams, support start-up through close-out, and contribute to audits and TMF documentation while upholding GCP/ICH and CDISC standards.

Qualifications

• 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 (Castor EDC, Rave, Inform, or equivalent).
• Proficiency with Power BI reports/dashboards; Power Query language experience a plus.
• Knowledge of industry standards (GCP, ICH, CDISC/CDASH).
• Proficiency with Microsoft Office; strong Excel skills.
• Experience working in cross-functional, multi-site clinical trial teams.

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.
• 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

EDC systems

Power BI

Data management

Cross-functional

Excel

Detail oriented

Communication

Education

Bachelor's degree in life sciences

Tools

Castor EDC

Rave

Inform

Job description

Shoulder Innovations LLC in Grand Rapids, MI is seeking a Clinical Data Associate to manage data across the study lifecycle within our medical device programs. You will work with EDC systems, ensure data quality, and support dashboards in Power BI to monitor data cleaning, site performance, and study metrics.

You will collaborate with cross-functional teams, support start-up through close-out, and contribute to audits and TMF documentation while upholding GCP/ICH and CDISC standards.