Senior Solutions Designer

Calyx

20h

About The Position

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, efficient 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.

Requirements

• Demonstrates deep understanding of IRT platforms.
• Familiarity with adaptive trial designs, double-blind/double-masked studies, and protocol customization.
• Ability to demonstrate a strong grasp of Good Clinical Practice (GCP) and biostatistical design principles.
• Demonstrable knowledge of integration processes between IRT and EDC systems, including validation and risk management workflows.
• Demonstrates understanding of working in and leading in an Agile environment (Scrum, Kanban).
• Familiarity with JIRA ticketing systems, user requirement specification templates, and SOP compliance for study builds and change requests.
• Demonstrable knowledge of in Scope Management.
• Knowledge of and ability to undertake thorough Root Cause Analysis.
• Excellent interpersonal, verbal and written communication skills.
• A flexible attitude with respect to work assignments and new learning.
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
• Must have the ability to work methodically in a fast-paced, time-sensitive environment.
• Demonstratable ability to apply critical thinking to problems and tasks.
• Shows initiative and self-confidence, is adaptable and is able to cope with changing and evolving priorities.
• Ability to identify and implement process improvements.
• Proactively participates in skills improvement training and encourages their teams to participate.
• A self-starter and able to work under own initiative.
• Maintains an up-to-date awareness of trends, tools, technology, techniques and processes that affect technology within the Life sciences domain.
• Experience using tools to communicate progress to Stakeholders.
• Experience of regulated environments (GxP, Financial, etc…).
• Expertise in randomization algorithms, cohort management, and complex dosing schedules.
• Experience with global clinical trials, including working across time zones and managing diverse client expectations.
• Demonstrable hands-on involvement in specification development, system validation, and go-live support.
• Proven experience of working in and knowledge of clinical development in the life sciences industry.
• Solid professional experience in the same or very similar role.
• Bachelor's Degree in a technical discipline (Maths, Science, Engineering, Computing, etc.) or a related study, or equivalent project-related experience.
• English: Fluent.

Nice To Haves

• Proven track record of designing and building studies across all phases and therapeutic areas (e.g., oncology, ophthalmology, allergy) preferred.

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 Experts, to identify potential risks and optimal study design. Collaborate with stakeholders to assess risk impact and likelihood and propose mitigation strategies. Integrate risk management practices into design documentation and decision-making processes. Analyze and identify recurring risk patterns and trends across multiple projects to inform proactive design improvements and strategic planning.
• Relationship management Helps develop and enhance client and stakeholder relationships, and is able to influence customers, suppliers and partners Build and maintain strong working relationships with internal stakeholders, including business units, project managers, and technical teams. Act as a trusted advisor to stakeholders by understanding their needs and translating them into effective solution designs. Facilitate clear and consistent communication between cross-functional teams throughout the study lifecycle. Collaborate with external vendors and partners to ensure alignment with solution requirements. Manage stakeholder expectations by providing timely updates, addressing concerns, and negotiating compromises when necessary. Deals with problems and issues, managing resolutions, corrective actions, lessons learned and the collection and dissemination of relevant information. Promote a collaborative and inclusive environment that encourages feedback and continuous improvement. Foster long-term partnerships by demonstrating value, reliability, and responsiveness in solution delivery.
• Business process improvement Contributes to the definition of organizational policies, standards, and guidelines for business process improvement Assists with analyzing and designing business processes, identifying alternative solutions to exploit new technologies and automation. Assists in assessing the feasibility of business process changes and recommends new approaches. Assists to select, tailor and implement business process improvement methods and tools at program, project and team level in line with agreed standards.
• Other Carryout any other reasonable duties as requested.

Benefits

• Medical, Dental and Vision benefits for you and your family, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSAs)
• Paid time off policy including holidays and sick time
• Internal growth and development programs & trainings
• 401(k) program, life & accident insurance and disability insurance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level