Develop and Manage User Requirements
Responsible for ensuring the process of gathering, analyzing, refining, and finalizing user requirements from multiple sources, in an iterative manner to ensure that product/study will be delivered to the Customer in timely and accurate manner.
Review specification document to ensure all field requirements are present and in the correct format.
Ability to take the initial study requirement categories and develop the complete set of specifications and other key elements for the user requirements document (URS).
Possess the interpersonal acumen to coordinate the schedules of multiple internal and external resources to ensure timely submission of a myriad of requirements throughout the URS process
Know how to tie product features and functionality to the requirements definition stage to reduce confusion and conflict during the testing and "go live" phases of a study
Ability to effectively manage the efforts involved in the build, test, and quality review tasks by the team such that key project milestones are met on a consistent basis.
Work closely with project managers and other internal resources throughout the project life cycle, coordinating many of the key product delivery tasks--standard and customized specification development, configuration tasks and documentation, use cases, test plans, data management, training requirements, and quality control.
Maximize the use of templates, checklists, and other job aids for routine data collection to focus attention on the more critical and complex elements of a study project plan
Routinely review timelines with project managers and/or customers to ensure that all deliverables will be met.
Subject Matter Expertise
Generally, considered to be a subject matter expert (SME) on a particular BioClinical product.
Recognized as the technical expert for the requirements process and can continuously move internal and external specifications discussions in a forward and positive direction
While maintaining respect for others knowledge and position, be able to effectively lead a diverse team from requirements definition to product sustainability
Working within a time-constrained environment, account for the longer-term project deliverables in the Define stage of the project life cycle (PLC) and establish realistic milestones related to effective requirements management
Education: Bachelor’s degree
Experience: With bachelor’s degree, 2-3 years experience. Experience of 5+ years, in lieu of a bachelor’s degree.
Additional skill set: Knowledge of interactive response technologies, drug supply, randomization schemes, etc.