Clinical Data Specialist

2 weeks ago

Dublin, Dublin City, Ireland beBeeClinical Full time €96,000 - €128,000

Role Description:

We are seeking a highly skilled and experienced Clinical Data Specialist to join our team. The successful candidate will be responsible for producing standard and custom reports for the Clinical Data Managers, developing transfer specifications with vendors, and performing Study Data Tabulation Model (SDTM) conversion programming and Quality Control (QC).

Main Responsibilities:
  • Extract clinical data from the clinical data management system and produce standard and custom reports in SAS.
  • Program reports and listings as requested by project team members.
  • Develop transfer specifications with vendors for external data sources.
  • Perform consistency checks on data transferred between us and external parties to ensure completeness and accuracy of data contained transfers.
  • Perform programming to convert raw, clinical trial data to Study Data Tabulation Model (SDTM) format.
  • Perform Quality Control (QC) on programming work performed by fellow Database Programmers.
  • Create and validate global macros or systems that streamline repetitive operations to increase programming efficiency.
Required Skills and Qualifications:
  • Bachelor's degree or certification.
  • Minimum of 5 years of clinical SAS programming experience in the pharmaceutical industry.
  • Working knowledge of CDISC SDTM mapping/specs/conversion/domains/datasets/eCRF/eCRT Package/define.xml development and SDTM data transfer operations on clinical studies.
  • Understanding of regulatory requirements relevant to submissions.
  • Knowledge of clinical trial study design and electronic data submission requirements.
  • Communication and interpersonal skills and the ability to work effectively as part of a team.
Benefits:
  • Ongoing training and professional development opportunities.
  • A supportive and collaborative work environment.
  • The opportunity to work on a wide range of projects and contribute to the success of the company.
Others:

This is an exciting opportunity for a motivated and talented individual to join our team and contribute to the delivery of high-quality results.

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