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Solutions Designer (IRT expertise required)

LE1233 Perceptive eClinical Ltd
Full-time
On-site
GBR - Decentralized United Kingdom
Pharmaceuticals

We’re on a mission to change the future of
clinical research. At Perceptive, we help the
biopharmaceutical industry bring medical
treatments to the market, faster.
Our mission is to change the world
but to do this, we need people like you.

What can we offer you?

Apart from job satisfaction, we can offer you:


YOURSELF
• 25 days’ holiday (with the option to buy more)


HEALTH
• Health Cash Plan
• Optional private health, dental insurance, and health screens
• Cycle to work scheme


WEALTH
• Generous pension scheme with up to 10% employer contribution
• Life assurance
• Season ticket loan

About the role

Job Purpose

As Solutions Designer (SD) your role is focused on translating clinical trial protocols into optimized IRT implementations that ensure accurate randomization, efficient supply management, and regulatory compliance.

SDs 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, SDs proactively identify risks, drive process improvements, and support go-live readiness for global clinical studies.

Key Responsibilities:

Requirements definition & management:

  • Defines and manages scoping, requirements definition and prioritization activities for small-scale changes and assists with more complex change initiatives.
  • 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 stakeholder are updated.

Risk management:

  • 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:

  • 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:

  • 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.

Functional Competencies (Technical knowledge/Skills)

  • 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

Knowledge, Education and Experience

Please note: a deep understanding of IRT platforms is a mandatory requirement to be considered for this role

  • Experience of working in and knowledge of the life sciences sector
  • Expertise in randomization algorithms, cohort management, and complex dosing schedules
  • Familiarity with adaptive trial designs, double-blind/double-masked studies, and protocol customization
  • Strong grasp of Good Clinical Practice (GCP) and biostatistical design principles
  • Knowledge of integration processes between IRT and EDC systems, including validation and risk management workflows
  • Proven track record of designing and building studies across all phases and therapeutic areas (e.g., oncology, ophthalmology, allergy) preferred
  • Experience with global clinical trials, including working across time zones and managing diverse client expectations
  • Hands-on involvement in specification development, system validation, and go-live support
  • Familiarity with JIRA ticketing systems, user requirement specification templates, and SOP compliance for study builds and change requests
  • Knowledge of and experience in Scope Management
  • Knowledge of and experience Root Cause Analysis
  • English: Fluent

Come as you are.
We're proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, colour, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.