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Business Solutions Architect at Endpoint Clinical · Katori

About Us:

Endpoint is an interactive response technology (IRT®) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE® platform, have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. Endpoint is headquartered in Raleigh-Durham, North Carolina with offices across the United States, Europe, and Asia.

Position Overview:

The Business Solutions Architect is responsible for the creation and management of the requirements and technical documentation for IRT projects. Business Solutions Architects work closely with the client, Project Managers, and technical teams to ensure that each system is built and updated to meet the needs of the protocol.

The Business Solutions Architect (BSA) independently delivers business analysis for low-to-medium complexity initiatives. The role translates business needs into clear, actionable requirements and ensures alignment between business and technical teams.

Responsibilities:

Demonstrate strong working knowledge of technologies used in life sciences and clinical trial environments, including RTSM platforms.

Lead requirements elicitation and documentation for assigned initiatives, translating business needs into clear, actionable, and compliant functional requirements.

Facilitate workshops, discovery sessions and process reviews to drive shared understanding of study and system needs.

Collaborate with clients to elicit, analyse, and document system requirements, enhancements and changes throughout the study lifecycle.

Analyse business processes, data flows, and system interactions to ensure alignment between business objectives and technical solutions.

Serve as a subject matter expert on assigned clinical study protocols, supporting studies of moderate to high complexity.

Author clear, accurate, and compliant functional specifications for RTSM systems, including randomization, kit lists, integrations and interfaces.

Partner effectively with internal teams (Project Management, Development, QA, Operations, and Support) to advance initiatives through all phases of the development lifecycle.

Support UAT planning, execution and defect triage, ensuring timely issue resolution and optimal study designs.

Manage requirements changes in line with established governance and escalation processes, ensuring traceability and risk awareness.

Continuously expand knowledge of Endpoint platforms, processes and offerings as they evolve.

Understand and assess the operational and strategic impact of system issues (e.g., unblinding risk, supply shortages, patient randomization or dosing challenges).

Apply and reinforce Endpoint processes while supporting client‑specific study designs and ongoing maintenance.

Collaborate with process owners and provide constructive feedback to improve study maintenance and operational efficiency.

Identify risks and issues early, escalating appropriately based on impact and urgency.

Manage system designs across multiple studies and client templates, ensuring consistency and quality.

Build trust through transparency, accountability and the ability to engage in clear, respectful and constructive conversations when needed.

Perform other duties as assigned, consistent with business needs and the scope of the position.

Accountabilities:

Demonstrates timely, accurate and high‑quality delivery of Business Analysis outputs within assigned initiatives.

Is accountable for maintaining clear, complete and traceable requirements that support compliant and effective system designs.

Effectively utilises available resources to support on‑time study delivery while maintaining appropriate oversight and accountability.

Builds and maintains effective working relationships with stakeholders, demonstrating confident facilitation and professional stakeholder management.

Delivers work with a consistent level of reliability, quality and attention to detail, reflecting solid Business Analysis capability and accountability for outcomes.

Authority:

The Business Solutions Architect is authorised to own Business Analysis deliverables within the assigned scope of work.

Makes analysis and requirements decisions within established frameworks, standards and governance processes, escalating where impact or risk exceeds defined thresholds.

Is authorised to engage directly with business users, subject matter experts and delivery teams to elicit requirements, validate solutions and support study delivery.

May assess and communicate risks related to RTSM system designs, requirements changes and study impacts, providing informed recommendations within established governance and escalation frameworks.

Education:

Bachelor's degree or equivalent preferred; appropriate experience in the RTSM industry may substitute for the degree requirement.

Experience:

2+ years of experience in clinical trials, RTSM/IRT, clinical supply chain, or a related life sciences/technology field

2-4 years experience in the life science industry .

Previous experience working in a fast-paced, entrepreneurial environment preferred.

Familiarity using SQL a plus

Skills:

Strong attention to detail and quality-focus

Strong customer service orientation

Excellent organizational and time management skills

Good communication skills

Excellent organizational skills

Strong interpersonal skills with the ability to work effectively with a wide variety of professionals

Solid written communication, including the ability to effectively document technical information

Able to work on multiple assignments with moderate supervision

Endpoint Clinical does not accept unsolicited resumes from search firms or any other third parties. Any unsolicited resume sent to Endpoint Clinical will be considered Endpoint Clinical property, and Endpoint Clinical will not pay a fee should it hire the subject of any unsolicited resume.

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Business Solutions Architect