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Shoulder Innovations
Shoulder Innovations
11 – 50 Darbinieki
Farmaceitiskie produktiRažošanaVeselības aprūpe
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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Vakances uzņēmumā

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.

USAmerikas Savienotās ValstisMIMičigana
70 000 $ – 85 000 $ / gads
AttālinātiPilna slodzeJaunākais speciālistsVidējais līmenisNepieciešamā Valoda: angļuAsociētais speciālistsVispārīgi
Google Cloud Platform

Apraksts

  • 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.

Prasības

  • 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.

Priekšrocības

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

Saistītās vakances

Parexel

Senior Clinical Research Associate, Contractor – Australia

Parexel
H1B vīzas sponsorsKonsultācijasLoģistikaVeselības aprūpe
AUAustrālijaAttālinātiPilna slodzeVecākais speciālistsNepieciešamā Valoda: angļuKlīniskā pētniecība
Google Cloud Platform

Monitor clinical trial sites across Australia for Parexel, overseeing protocol compliance, data quality, documentation, and trial deliverables. This contractor role covers site activities from study initiation through closeout.

Atvērt
Qureight

Senior Clinical Data Manager, Imaging

Qureight
1 – 10 Darbinieki
BiotehnoloģijaMākslīgais intelektsVeselības aprūpe
GBApvienotā KaralisteHibrīdiPilna slodzeVecākais speciālistsNepieciešamā Valoda: angļuKlīniskā pētniecība
AWSGoogle Cloud Platform

Lead imaging data quality, sponsor transfers and user acceptance testing for Qureight’s AI-powered clinical trial platform. Oversee DICOM quality control and clinical data processes while supporting junior team members.

Atvērt