Analyst I, Clinical Technology

Lake County, IL

Posted: 07/07/2022 Job Number: 21043090

Job Description

Project Description:
  • The client' s Data Science (DS) is the best-in-class team within its cross-industry peer group.
  • We are responsible for bringing people, process, and technology together to generate business value from clinical trials data.
  • Our operational model is exemplified through execution and innovation.
  • This role is a key to ensuring successful delivery against the program- and study-level accountabilities assigned to Data and Statistical Sciences (DSS).
  • Develops deep understanding of supported technology domain and achieves skill set required to fully support the system.
  • Utilizes defined standards and domain-specific knowledge to support clinical data flow from collection to analysis-ready datasets.
  • Defines and develops electronic data capture systems for the collection of clinical trials data which are compatible with SDTM requirements.
  • Builds specifications for data acquisition from third-party systems.
  • Defines and develops systems integrations.
  • Identify and resolve any issues with the external data acquisition.
  • Builds specifications for interactive response technology and ePRO.
  • Creates operational analytics to support ad hoc analyses and metrics reporting.
  • Acts as general DS technology point of contact and works closely with data and statistical colleagues to troubleshoot data or process flow interruptions, as well as potential errors.
  • Maintains technical knowledge of and supports one or more data systems and uses knowledge of how the capability contributes to the submission data flow and overall DSS technology strategy.
  • Collaborates with global functional teams including IT and technology specialists from peer organizations.
  • Maintains supported domain as an element of the DSS tech strategy.
  • Responsible for mentoring Data Science Associates.
  • Participates in functional innovation and process improvement initiatives.
  • Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, company Standard Operating Procedures (SOPs), and to functional quality standards.
  • Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development.
  • Acts as the clinical data systems SME during regulatory inspections and internal quality audits.
  • Administers and supports the sFTP server set up for external data transfers with third party vendors.

Required Skills:
  • Bachelor' s degree in business, management information systems, computer science, life sciences, engineering or equivalent.
  • Master' s preferred.
  • 4+ years of pharmaceutical, clinical research, data management, health care technology experience or 6+ years of broader technology experience.
  • Familiar with clinical trial process and clinical technology.
  • Demonstrated knowledge of SAS and/or SQL programming skills and knowledge of database concepts.
  • Familiar with CDASH and SDTM Standards.
  • Demonstrated leadership traits and ability to influence without authority.
  • Demonstrated effective communication skills.
  • Demonstrated effective problem-solving and analytical skills.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Bridget: bridget@alphaconsulting.Com


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Bridget Burns

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