Clinical Data Coordinator - Munich, Deutschland - Linical Europe

Linical Europe
Linical Europe
Geprüftes Unternehmen
Munich, Deutschland

vor 1 Monat

Lena Wagner

Geschrieben von:

Lena Wagner

beBee Recruiter
Beschreibung
Linical Co., Ltd.

('Linical') is a premier global CRO headquartered in Osaka, Japan, listed in the prime segment of the Tokyo Stock exchange, and dedicated to serve its clients as a true partner in development.

With more than 700 employees Linical directly covers a total of more than 20 countries in Europe, North America and Asia-Pacific including Japan via its own offices and staff.

Linical's European arm is headquartered in Frankfurt, Germany with a substantial presence in Paris and Madrid. Its geographic footprint facilitates a significant presence in the leading Western European markets, combined with well-established affiliate operations in key emerging markets in Central
- and Eastern Europe.


Role description:


The Clinical Data Coordinator (CDC) is responsible for manually reviewing Case Report Forms (eCRFs) and the output of electronic edit check programs according to established Data Management (DM) Plans; generates, tracks, and resolves data queries; and follows up with clinical sites regarding outstanding queries, missing and overdue data.


Main responsibilities:


  • Regularly informs the Clinical Data Manager of overall project task status and potential risks
  • Drafts the studyspecific eCRF Completion Guidelines (CCGs) based on final eCRFs
  • Performs User Acceptance Testing (UAT) of the EDC database
  • Performs tasks related to all aspects of the data cleaning process from study startup through database lock o Reviews study database for incomplete data and outstanding data quality issues o Responsible for generation and resolution of data queries o Works with sites and Clinical Research Associates to follow up on query responses and errors identified during data cleaning
  • Supports SAE and external data reconciliation and issues queries as needed
  • Performs local lab module management in EDC when applicable
  • Performs the eCRF archiving process
  • Other duties as assigned

Required skills and abilities:


  • Well organized, with strong attention to detail and analytical ability
  • Able to meet critical milestones and timelines
  • Able to manage all assigned tasks efficiently and effectively, and to work on multiple tasks simultaneously
  • Excellent written and verbal communication skills
  • Adaptable to changes in work duties, responsibilities, and requirements
  • Dedication to quality in all work tasks and deliverables
  • Proficient in MS Office products
  • Fluent English skills

Education & Experience:


  • Associate's or Bachelor's degree or equivalent experience; healthrelated field preferred
  • Years and type of experience: the CDC is an entrylevel position, requiring no previous clinical research experience
Senior CDC requires a minimum of two years of experience as a CDC


Other:

All applicants must be US- based and possess valid right to work documentation. All applicants must be US residents.

Linical is an equal opportunity employer.
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