Associate Solutions Design Analyst

Pittsburgh, Pennsylvania | Direct Hire

Post Date: 12/09/2016 Job ID: 13907 Industry: MISC

Associate Solutions Design Analyst
Pittsburgh, PA

We have an opening with our client in Pittsburgh, PA for an Associate Solutions Design Analyst. The Associate Solutions Design Analsyt will be responsible for delivering the highest quality ePRO and eCOA system design, specifications development and server as a subject matter expert for clients. Interested candidates should have a minimum 3 years of experience in documenting business and technical requirements for clinical software or systems.

Essential Duties and Responsibilities of the Associate Solutions Design Analyst

  • Function as Subject Matter Expert to advise internal and external clients on system functionalities
  • Responsible for gathering Sponsor requirements and specifying business rules, data structures, standard and custom reports for clinical trials.
  • Work with Project Manager to establish or refine scope definition and to provide work effort/duration estimates throughout the lifecycle of the study.
  • Gather and document the interpretation custom system configuration.
  • Translate study protocol and project-specific requirements into a design that optimizes data capture trial design applications.
  • Ensure consistency between trial data capture, delivery and structures to meet client requirements.
  • Assist in the evaluation of new product features.

Qualifications of the Associate Solutions Design Analyst

  • Minimum of 3 years of experience in documenting business and technical requirements for clinical software or systems
  • Ability to understand and interpret clinical trial documentation such as protocols, questionnaires and other data collection instruments, and clinical data models
  • Understanding of clinical trial data management and database structure and design
  • Demonstrated experience in interpretation of client requirements to prepare and document design specifications
  • Ability to work within cross functional team, both internal and external
  • Working knowledge of modern EDC and/or ePRO systems
  • Familiarity with FDA regulatory processes, clinical research processes and CDISC standards
  • Self directed - comfortable working in a fast-paced and deadline-driven environment
  • Ability to manage multiple project tasks and deliverables
  • Proven problem-solving skills and attention to detail
  • Excellent presentation, communication (written and oral) and negotiation skills
  • Ability to travel up to 25%
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