Clinical Data Associate

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 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.

Your responsibilities will include, but are not limited to the following:

Data Management

• 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

EDC & Systems

• 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

Reporting & Monitoring (Power BI)

• 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

Project & Study Support

• 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

We believe to be successful as a Clinical Data Associate, you will have the following:

• 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 (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

We value and appreciate our employees and will support you with great company culture, opportunities for professional growth, competitive wages, and benefits. To learn more about us, visit us online at https://shoulderinnovations.com.