Senior Clinical System Analyst

Location: Bothell / Seattle, WA
Date Posted: 09-21-2017
Summary:
This position is responsible for the successful delivery and business support of systems for Clinical Development; the delivery of business intelligence and analytics; and ensuring that systems are operational and GCP compliant where required. Daily activities may include application administration, project management, business analysis, end user training, and issue identification and trouble shooting. May provide other technical consulting support for the Clinical Development department.
 
Responsibilities:
  • Lead or participate in the implementation of new systems as a member of the project team, providing technical expertise and analysis.
  • Roles include project management, business analysis, test management, and technical expert
  • Design and develop complex reports in support of assigned customer group(s).
  • Reports may be for regulatory submissions, safety review or other ad hoc business needs
  • Identify report and/or system requirements by interviewing customers; analyzing department applications, programming, and operations; and evaluating existing systems
  • Manage and monitor designated applications and databases and take corrective action to prevent or minimize system issues
  • Troubleshoot to resolve system-related problems; coordinate with relevant IT staff and/or third party vendors regarding user support and problem resolution
  • Provide production support for assigned customer group(s) and serve as technical expert for assigned technology(ies); identify issues and design and implement solutions to address them
  • Create user documentation and train personnel on applications/reports/solutions, as required
  • Develop and maintain SOPs, work practices and training guides; ensure documents reflect current practices and are consistent across documents
  • Develop system-specific procedures, programs, scripts, or web pages as required
  • Follow systems validation procedures and author related documentation
  • Maintain quality service by establishing and following standards
  • Ensure assigned system(s) meet service level agreements with end users both internal and external
  • Serve as liaison with IT and QA
  • Serve as mentor and department resource for system related issues
  • Keeps current with the latest technology; regularly attends technical training in order to maintain technical expertise
 
Qualifications:
  • This position requires an individual with previous experience in the biotech/pharma or medical device industry
  • 5-10 years experience performing the duties and responsibilities listed above
  • Demonstrated proficiency in business analysis or project management
  • Experience implementing and validating systems in a biotechnology or pharmaceutical company
  • Knowledge of at least one of the following industry business areas: Drug Safety, Clinical Operations, Regulatory Affairs, Translational Medicine / Biomarkers, Medical Affairs, Clinical Programming, Biostatistics
  • Experience with business intelligence tools (e.g. Spotfire, Cognos, Business Objects, Tableau, OBIEE, etc.)
  • Excellent communication and organization skills
  • Ability to proactively plan, organize and function with minimal oversight
 
Preferred:
  • Knowledge of CFR and GCP/ICH requirements, as well as European Clinical Trial Directive
  • Experience administering applications
  • Experience working in or administering SQL Server databases
 "This posting is for FTE"

 
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