Solution Architect BSA Clinical RD IT

Spinnaker Search; Nutley (NJ); On-site; USD 120,000 - 150,000; Full time

Job summary

Spinnaker Search has partnered with a research-driven pharmaceutical company to hire a Solution Architect / Sr. Technical Clinical Systems Analyst.

The role focuses on translating business needs into practical architecture and documentation for a broad Clinical R&D portfolio hosted primarily on AWS. The position is direct-hire and individual contributor, offering growth in a complex, regulated environment with exposure to GxP, data integrity, privacy, and security considerations.

Qualifications

• Bachelor's degree in a relevant field and at least five years of related technology experience.
• Proven experience gathering business/IT requirements and defining technology solutions or remediations.
• Ability to create architecture documentation and technical proposals, working with specialist architects when appropriate.
• Familiarity with AWS-hosted applications and cloud-based enterprise technology environments.
• Practical understanding of GxP regulatory expectations and their impact on architecture, validation and data integrity.
• Ability to assess existing computing environments, identify improvements, and keep technical documentation current.

Responsibilities

• Gather requirements and propose practical technology solutions or remediations.
• Prepare and maintain architecture documentation and design decisions, drawing on expert input where needed.
• Learn the existing portfolio of 80-100 Clinical R&D technologies and identify gaps.
• Consult on implementation of ongoing compute-environment initiatives.
• Help improve and clean up the architecture of existing environments and ensure accurate documentation.
• Account for GxP, validation, data integrity, privacy and security when evaluating designs.
• Present options, architecture decisions, risks and recommendations clearly to technical and business stakeholders.

Skills

Requirements gathering

Architecture documentation

Technical problem-solving

Stakeholder communication

AWS familiarity

GxP regulatory understanding

Team collaboration

Education

Bachelor's degree in a relevant field

Tools

AWS

Veeva

SAS/SAS Viya

Job description

Behind every clinical trial is technology that researchers depend on to manage data, analyze results, and advance therapies. A research-driven pharmaceutical company is seeking a Solution Architect / Sr. Technical Clinical Systems Analyst who enjoys understanding business needs, working with technical specialists to define practical solutions or remediations, and putting clear architecture documentation behind those decisions. The role touches a broad Clinical R&D portfolio of roughly 80-100 technologies, most solutions hosted in AWS, with opportunities to strengthen existing computing environments and the architecture that supports them.

It's a direct-hire, individual contributor opportunity with broad exposure and room to grow.

The Role You'll Play

As the Solution Architect, you will work with Clinical R&D business partners and other IT teams to understand requirements, agree on appropriate solutions or remediations, and document the technical architecture and proposals. You will collaborate with more specialized architects and engineers where needed rather than be expected to personally design every technical component.

• Partner with business and IT stakeholders to gather requirements and propose practical technology solutions or remediations.

• Prepare and maintain architecture documentation, technical solution proposals, integrations and design decisions, drawing on expert input where needed.

• Learn the existing portfolio of approximately 80-100 Clinical R&D technologies, identifying architecture and documentation gaps.

• Consult on implementation of an ongoing computing-environment initiative whose architecture is already defined.

• Help improve and clean up the architecture of a separate existing computing environment and ensure accurate supporting documentation.

• Account for GxP regulatory requirements, validation, data integrity, privacy and security when evaluating technical designs.

• Partner with enterprise infrastructure, security, platform teams, other architects and vendors across AWS-based and related solutions.

• Present solution options, architecture decisions, risks and recommendations clearly to technical and business stakeholders.
  

Background Profile

The strongest candidates are practical technical problem-solvers who can turn business requirements into well-reasoned solutions and then document the architecture clearly. The role requires a working understanding of how GxP requirements affect technical decisions. Experience as a Solution Architect is relevant, but a strong Technical Business Systems Analyst or Clinical Systems Analyst with genuine solution-design and documentation experience may also fit.

• Bachelor's degree in a relevant field and at least five years of related technology experience.

• Proven experience gathering business/IT requirements and defining technology solutions or remediations.

• Ability to create architecture documentation and technical proposals, working with specialist architects when appropriate.

• Familiarity with AWS-hosted applications and cloud-based enterprise technology environments.

• Practical understanding of GxP regulatory expectations and their impact on architecture, validation and data integrity.

• Ability to assess existing computing environments, identify improvements, and keep technical documentation current.

• Strong communication skills and experience coordinating business partners, shared IT teams, technical experts and vendors.

• Preferred: clinical R&D, pharmaceutical, biotech or CRO experience; exposure to Veeva, SAS/SAS Viya or clinical computing platforms is a plus.

Compensation

$120,000-$150,000 per year