Clinical Data Associate

Clinical Data AssociateShoulder 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. We're seeking entrepreneurial talent to join us on this exciting journey. 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:Perform comprehensive data management tasks including data review, query generation, and query resolutionSupport all study phases: Start-up, Execution, Database Lock, and Close-outPerform 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 appropriateReceive and reconcile imaging dataManage eCRF freeze/lock activitiesFile documentation in the Trial Master File (TMF)Support study closeout and archiving activities, including QC of subject/site CRFsServe 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 exportGenerate reports directly from the EDC system to track data cleaning progress and outstanding queriesPerform DM quality review and other internal QC checks per applicable EDC systemsSupport EDC-related testing (edit checks, validation rules, user acceptance testing) during study build and amendmentsMaintains 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 stakeholdersMaintain and troubleshoot existing Power Query/Power BI data pipelines feeding from EDC exports and other source systemsEnsure dashboard data accuracy through regular reconciliation against EDC source dataAttend study-related meetings and teleconferencesTrack project progress and issue periodic status/metric reportsAssist in identifying achievement of milestones per study timelinesParticipate in finalization and transfer of the clinical database and related documents to the sponsorParticipate in internal meetings and internal/external audits as requiredMaintain awareness of contract scope and study-specific Clinical Data Management PlansWe 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 researchClinical data associate/management experience at a CRO, pharma, medical device, or biotech companyHands-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 requiredExperience working in cross-functional, multi-site clinical trial teamsIf you are looking to further your career in a pioneering and evolving industry, apply today for our Clinical Data Associate position. We value and appreciate our employees and will support you with great company culture, opportunities for professional growth, competitive wages, and benefits.