Senior Clinical Systems Analyst

Location
Bothell, Washington State (US)
Salary
Commensurate with experience
Posted
Apr 25, 2018
Closes
Jun 25, 2018
Ref
1703KR-01 #LI-KM1
Category
Pharmaceutical
Career Fair Category
Career Fair

<p>Seattle Genetics is passionate about making a positive impact on the lives of patients with cancer. Employees bring that enthusiasm to everything they do, striving to attain their individual goals while recognizing the power of working collaboratively to realize Seattle Genetics' vision of improving patient outcomes. View this career recruitment video to learn about Seattle Genetics' culture and hear directly from chemists, clinical researchers and sales professionals. As a company working at -- and advancing -- the cutting edge of antibody-based therapies, Seattle Genetics fosters an environment that recognizes the challenges of breaking new ground and creates opportunities for intellectual and professional growth. State-of-the art facility gives our team members the resources to succeed. Located in Bothell's Canyon Park area, Seattle Genetics is close to major highways, dining and shopping. If you are passionate about bringing the best of yourself to everything you do, Seattle Genetics offers challenges, opportunities and rewards for making your best even better. We want to hear from you!</p>

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

Seattle Genetics is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.