Clinical Data Associate

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

Preferred

Development experience is a plus

Power Query/M language experience a plus

Benefits

Great company culture

Opportunities for professional growth

Medical devices for glenoid fixation in shoulder arthroplasty.

Holland, Michigan, USA

http://shoulderinnovations.com/

Public Company

Total Funding

$312.9M

Key Investors

Stifel Venture Banking and Lending Group

Fidelity

U.S. Venture Partners

2026-06-29

Post Ipo Debt· $45M

2025-07-31

IPO

2025-07-21

Convertible Note· $115M

Leadership Team

Robert Ball

Chief Executive Officer

Jon Osborne

Chief Commercial Officer

Recent News

PR Newswire

Shoulder Innovations Initiates Commercial Launch of the InSet® Go

2026-10-08

Morningstar.com

Shoulder Innovations Receives FDA 510(k) Clearance for N-22 Humeral Head and Initiates Full Commercial Launch

2026-09-11

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 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 is a plus

Power Query/M language experience a plus

Required skills

Clinical Data Management, Electronic Data Capture (EDC), Power BI, Power Query / M, Clinical Practice (GCP), ICH Guidelines, CDISC/CDASH, Microsoft Excel, Clinical Research, Clinical Trials

Preferred skills

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

Experience

Mid level