As Senior Solutions Designer (SD), you may sit within multiple areas of the business, to facilitate the generation of value from our products and services for both internal and external customers. You will work with other levels of the SD team and multiple other stakeholders, taking ownership of substantial process improvements and initiatives. In this role, you will be focused on translating clinical trial protocols into optimized IRT implementations that ensure accurate randomization, productive supply management, and regulatory compliance. You will collaborate with cross-functional teams to gather requirements; design scalable solutions using various platforms and maintain meticulous documentation throughout the study lifecycle. With deep expertise in trial design and system capabilities, this role proactively identifies risks, drives process improvements, and supports go-live readiness for global clinical studies.
Key Responsibilities
Requirements definition & management
Defines and manages scoping, requirements definition and prioritization activities for large, complex initiatives.
Obtains input from, and formal agreement to, requirements from a diverse range of stakeholders
Follows agreed standards, applying appropriate techniques to elicit and document detailed requirements.
Provides constructive challenge to stakeholders as required.
Prioritizes requirements and documents traceability to source.
Reviews requirements for errors and omissions.
Provides input to the requirements baseline.
Supports authorized requests for changes to base-lined requirements, in line with change management policy.
Ensures all relevant documentation is maintained in accordance with relevant regulatory Guidelines and SOP’s ensuring all relevant stakeholders are updated.
Risk Management
Is able to identify and communicate risks early in the development process and implement a risk-based approach to project related decision making
Works with internal stakeholders and Subject Matter