Solution Architect / BSA - Clinical R&D IT
Summary
A research-driven pharmaceutical company in Nutley, NJ is hiring a Solution Architect/Sr. Technical Clinical Systems Analyst to gather requirements from Clinical R&D business partners, define solutions or remediations, and document technical architecture across a portfolio of ~80-100 technologies, mostly AWS-hosted, with GxP regulatory compliance in mind.
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.
