Update 2 22 08 - position is pending on award of contract.

Title: Senior Informatics Quality Analyst
Salary: $90K + DOE
Location: Silver Spring, MD

My Client is building some of the most advanced clinical and laboratory informatics systems on the planet. Ideal attributes are exceptional intelligence, tremendous passion, and a willingness to constantly challenge conventional thinking with creative and innovative ideas to help make it possible to deliver breakthrough treatments and medical technologies to people throughout the developing world.

Job Description:
My Client is seeking an outstanding candidate for the newly-created position of Senior Informatics Quality Analyst. This person will work closely with some of the largest public health research teams in the world in our global efforts to combat the most complex diseases, including pediatric and adult AIDS. This person will work with top scientists and clinicians at the National Institutes of Health, the Centers for Disease Control, and the US Agency for International Development, as well as the largest pharmaceutical companies in the world. International travel is possible, but not required.


FUNCTION:
The Senior Informatics Quality Analyst will work closely with some of the largest public health research teams in the world in our global efforts to combat the most complex diseases, including pediatric and adult AIDS. This person will work with top scientists and clinicians at the National Institutes of Health, the Centers for Disease Control and the US Agency for International Development, as well as the largest pharmaceutical companies in the world. International travel is possible, but not required.

DUTIES AND RESPONSIBILITIES:

• Extensive communication with stakeholders across all levels of the organization
• Extensive analysis of highly complex life-critical informatics processes
• Demonstrate mastery of rigorous Software Development Lifecycle (SDLC)
• Ensure that systems are developed and supported in accordance with the SDLC and applicable FDA regulations
• Provide insight and expertise on software quality practices throughout the SDLC
• Lead and participate in the development and creation of: Software Quality plans, Validation plans, Risk analyses, Test plans, Test scripts, Requirements-Design-Test Traceability analyses
• Provide leadership and creativity
• Lead in delivering best-in-class web-based software products, including: Patient Health Information, Adverse Events Reporting, Complex Analytics Reports, Financial Disclosure, Core and Esoteric Laboratory data management, Protocol Workflow, Investigational and New Drug Application regulatory management, FDA Data Submission management, Global Logistics,
• Clinical Site Management, Investigator management and global Conference logistics

Required Skills:

• Required Experience Five (5) or more years preferred varied experience in Software Development, Product Development, Validation, and Quality.
• Expertise in data exploration and preparation with large datasets, and in study design and execution required.
• Expert-level ability to conduct research w/ web-based resources
• Experience with software development in a regulated environment or industry
• Strong Informatics skills in data/information presentation Expertise in software quality principles and practices
• Established project management skills Detail oriented, with ability to follow through to successful completion
• Ability to work with people at all levels of the organization Requirements analysis through test completion and User Acceptance
• Technical writing of software documentation
• Ability to function effectively as a team member in a highly collaborative environment
• Ability to work independently on multiple simultaneous projects and excellent communication skills.