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Clinical Data Specialist

Artivion, Inc.Kennesaw, GA

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Job Description

Company Overview:

Headquartered in suburban Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple, elegant solutions that address cardiac and vascular surgeons' most difficult challenges in treating patients with aortic diseases. Artivion has over 1,400 employees worldwide with sales representation in over 100 countries. The Company has manufacturing facilities located in Atlanta, Georgia, Austin, Texas and Hechingen, Germany. Additionally, it has sales and distribution offices in various countries throughout Europe, Asia, and South America. For additional information about Artivion, visit our website, www.artivion.com.

Position Overview & Responsibilities:

Manage assigned departmental project tasks/systems in principal areas of responsibilities identified below:

  • Assigned to low and moderately complex project tasks, supporting a Clinical Data Manager.
  • Works under the direct supervision of an experienced Clinical Data Manager.
  • Collaborates with internal and external partners as instructed.
  • Follows processes as described in Work Instructions, SOPs and as instructed.
  • Assists in the development and modification of clinical databases.
  • Executes UAT.
  • Drafts modifications in eCRF specifications.
  • Drafts edit/manual checks and CCGs.
  • Performs user management and system administration for utilized electronic systems.
  • Reviews clinical data using edit/manual checks and listings and provides query management.
  • Programs, validates and/or executes study-specific reporting tools.
  • Performs vendor data reconciliation.
  • Files Clinical Data Management documents and performs document completion checks.
  • Performs quality checks as instructed by senior CDM team members.
  • Generates data export, if applicable.
  • Maintains financial tracker.
  • Confirms performed service in invoices.

Qualifications:

  • 1-3 years' experience.
  • Bachelor's degree
  • Strong analytical skills
  • Proficiency with computer software programs

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