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Shoulder Innovations
Shoulder Innovations
11 – 50 Zaposleni
Farmacevtski izdelkiProizvodnjaZdravstveno varstvo
Shoulder Innovations is a medical device company focused on shoulder replacement. Its work centers on the InSet™ Glenoid, a technology designed to improve glenoid fixation, an important part of shoulder arthroplasty. The company develops solutions to address limitations in traditional fixation methods, with the aim of supporting more durable procedures and better patient outcomes.
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Delovna mesta v podjetju

Clinical Data Associate

Manage clinical trial data and reporting for Shoulder Innovations, a medical device company focused on shoulder replacement. The role uses EDC systems and Power BI to support data review, reconciliation, and study closeout.

USZdružene države AmerikeMIMichigan
70.000 $ – 85.000 $ / leto
Na daljavoPolni delovni časJuniorSrednja ravenZahtevani Jezik: angleščinaSodelavecSplošno
Google Cloud Platform

Opis

  • Review clinical data, generate queries, and resolve data issues.
  • Support study start-up, execution, database lock, and closeout.
  • Reconcile data from EDC, imaging, and third-party vendors.
  • Review discrepancy and edit-check outputs and validation listings against the Data Management Plan.
  • Resolve answered queries and issue follow-up queries when needed.
  • Receive and reconcile imaging data.
  • Manage eCRF freeze and lock activities.
  • File study documentation in the Trial Master File.
  • Support study closeout and archiving, including quality checks of subject and site CRFs.
  • Use the EDC system for routine work, with awareness of form and field configuration, user access, and data exports.
  • Create EDC reports to monitor data cleaning progress and open queries.
  • Conduct data management quality reviews and internal checks.
  • Assist with EDC testing during study builds and amendments.
  • Maintain Power BI dashboards and reports on data cleaning, query aging, site data quality, and monitoring visit findings.
  • Present data management metrics in clear visual reports for internal stakeholders.
  • Maintain and troubleshoot Power Query and Power BI data pipelines.
  • Check dashboard accuracy by reconciling figures with EDC source data.
  • Attend study meetings and teleconferences.
  • Track project progress and prepare periodic status and metrics reports.
  • Help monitor milestone progress against study timelines.
  • Support finalization and transfer of the clinical database and related documents to the sponsor.
  • Attend internal meetings and participate in internal or external audits as needed.
  • Stay informed about contract scope and study-specific Clinical Data Management Plans.

Zahteve

  • Bachelor’s degree in health, science, or a related field, or equivalent clinical research experience.
  • Experience in clinical data associate or management work at a CRO, pharmaceutical, medical device, or biotech company.
  • Practical experience with EDC systems such as Castor EDC, Rave, Inform, or an equivalent platform.
  • Proven ability to manage reports and dashboards in Power BI.
  • Power Query or M language experience is a plus.
  • Knowledge of current industry standards, including GCP, ICH, and CDISC/CDASH.
  • Proficiency in Microsoft Office, including Excel and Word.
  • Strong Excel skills.
  • Experience working with cross-functional teams on multi-site clinical trials.

Ugodnosti

  • Positive company culture.
  • Opportunities for professional development.
  • Competitive pay.
  • Benefits package.

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