21 CFR Part 11 jobs in Phoenix, AZ

Sr. Business Analyst with Clinical Trails _ 10+ Years Experience

Remote

•

Today

Position:1 Position- Business Analyst with Clinical Trails Location- Remote Job Description: The Business Analyst (BA) will serve as a key liaison between clients, product teams, clinical operations, and technical delivery teams. The BA will gather, analyze, and translate complex clinical trial requirements into functional specifications for eSource, DDC, and eCOA solutions. This role requires strong understanding of clinical trial processes, data capture workflows, regulatory expectations (Go

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Contract

Depends on Experience

Senior Computerized System Validation (CSV) Manager

Remote

•

19d ago

We are Looking for a Senior Computerized System Validation (CSV) Manager. This a full-time permanent hire position with our client. In this role you can work fully remote (anywhere in USA). In this role as a Senior Computerized System Validation (CSV) Manager, you will lead the transformation of CSV practices within the organization. In this role as a Senior Computerized System Validation (CSV) Manager you will ensure validation processes are risk-based, efficient, and compliant. You will be res

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Full-time

Depends on Experience

Clinical Systems Support Analyst / Research Data Manager (REDCap)

Remote

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21d ago

NeevSys is seeking a Clinical Systems Support Analyst / Research Data Manager to support clinical and translational research initiatives using REDCap. The selected candidate will support REDCap system administration, data management, and user training while collaborating with clinical investigators and research teams to ensure high-quality data collection and reporting. Key Responsibilities REDCap Administration Manage and maintain REDCap projects, configure data collection instruments, manage

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Full-time

$80,000 - $100,000

LabVantage LIMS Engineer

Remote

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Yesterday

Provide L2/L3 incident resolution for LIMS applications (LabVantage or LabWare). Diagnose and resolve configuration issues, workflow errors, sample lifecycle problems, and data inconsistencies. Conduct detailed root-cause analysis and implement permanent fixes. Maintain LIMS master data, workflows, templates, and stability modules. Support version upgrades, patches, and environment maintenance. Assist laboratory users with operational questions, access issues, and data troubleshooting. Support i

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Third Party, Contract

Depends on Experience

Clinical Business Analyst

Remote

•

Today

Title:Business Analyst Location:SFO,CA - Remote (Locals only from CA) Duration:Long term Experience:9+ Years Role Summary We are seeking an experiencedBusiness Analystwith strong domain knowledge inClinical Content Managementto support pharmaceutical product development. The role will focus on defining and implementing requirements forclinical content lifecycle automation, includingClinical Study Reports (CSR), regulatory documents, and protocol-related content. Job description Collaborate with

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Contract

Depends on Experience

Project Manager/Sr. Consultant

Remote or San Francisco, California

•

Today

Description We are looking for an experienced Project Manager/Sr. Consultant to contribute to the development of a robust Quality Management System tailored for pharmaceutical and life sciences applications. In this role, you will collaborate closely with AI engineers to ensure compliance with GxP regulations, while driving the creation and implementation of essential documentation and processes. This is a long-term contract position based in San Francisco, California. Responsibilities: Lead th

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Contract

USD 65.00 - 80.00 per hour

Validation Engineer

Remote or San Francisco, California

•

Today

Description We are looking for a skilled Validation Engineer to join our team in San Francisco, California. In this role, you will ensure that software systems meet established quality standards and adhere to regulatory requirements. You will work closely with cross-functional teams to design, execute, and maintain validation activities throughout the software development lifecycle. This position requires someone with keen attention to detail who is committed to improving processes and ensuring

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Full-time

USD 100,000.00 - 120,000.00 per year

Cloud Platform Architect

Remote

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8d ago

Role:Cloud/Platform Architect Location:Remote Type: Full time Role Summary Lead end-to-end architecture and delivery governance for a regulated AWS platform supporting CDAP (pharmacometrics) and BEE (biostats). Own multi-environment architecture (DEV/TEST/PROD/DR) using Terraform modularization and GitOps practices. Define platform blueprint for compute, storage, networking, identity, CI/CD, observability, DR, and operational readiness. Key Responsibilities Define target AWS architecture for VP

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Full-time, Third Party

1,20,000 - 1,30,000

Validation Engineer

Remote or San Francisco, California

•

Today

Description We are looking for a skilled Validation Engineer to join our growing team. In this role, you will ensure our software systems meet quality standards and comply with regulatory requirements. This role is to help build and define its validation function from the ground up. As an early team member, you'll shape core processes, own key deliverables, and interface with many different teams across the organization to embed quality throughout the SDLC. Responsibilities: Lead software valid

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Full-time

USD 90,000.00 - 110,000.00 per year

Principal IT Architect Medical Communications

Remote or North Carolina

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description The Principal IT Architect is a technology and architecture leader with broad knowledge of systems, services, software architectural concepts and system integration patterns. In this role, the Architect, is a member of the Clinical Research Group, aligned to the Medical Communications business unit. The Architect is responsible for understanding the business goals, requirements and objectives; and aligning these

Full-time

Associate Director, External Data Management

Remote or Warren, Ohio

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Today

The Associate Director, External Data Services, plays a critical leadership role, overseeing team members to ensure all activities align with Regeneron's procedures and industry best practices. This position collaborates closely with Clinical Data Management teams and External Data Vendors to deliver structured external data in compliance with Regeneron SOPs. The role also involves coaching, mentoring, and managing the performance of direct reports, while contributing to the department's strateg

Full-time

USD 157,200.00 - 256,600.00 per year

DIRECTOR OF TECHNOLOGY SOLUTIONS, DCRI

Remote or Durham, North Carolina

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Today

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,

Full-time

Manager, Software Development

Remote or Calexico, California

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Today

Manager, Software Development, Fresenius USA, Inc., a Fresenius Medical Care N.A. company, Martinez, California (Hybrid) Responsible for directing software systems development, software application development, and software quality assurance for software enhancements and new products including cloud-based and/or internet-related tools. Will manage a team of software developers to design, code, test, and implement high quality software for dialysis and related products. Will also be responsible

Full-time

USD 274,456.00 - 301,682.00 per year

Sr. IT Engineering Manager, Salesforce & Vault - Foster City

Remote or Foster City, California

•

Today

At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical ro

Full-time

USD 169,320.00 - 219,120.00 per year

Data Domain Lead, Real World Data (Director)

Remote or North Carolina

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Today

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher's PPD clinical research business, we're using digital innovation, data science, and AI to reimagine how life-changing therapies reach patients. Our teams combine deep scientific expertise with advanced analytics, automation, and digital platforms to make research smarter, faster, and more connected. At PPD we know that innovation happens when diverse minds meet. Our Digital Science, Data, and AI

Full-time

USD 185,000.00 - 215,000.00 per year

Director, ERP Boundary Systems Lead (Oracle Fusion)

Remote or Sleepy Hollow, New York

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Today

The Oracle Fusion ERP Boundary Systems Lead provides functional and technical oversight for key boundary applications supporting the Oracle Fusion Cloud modernization program-including but not limited to Icertis (Contract Lifecycle Management), Reval (Treasury), Zycus (iSource), Concur (Travel & Expenses), Serengeti, Pas-X MES, Kinaxis-APS, Veeva Vault, LIMS, Tracelink, Orchestrate, BlueMountain, Tririga, and Nemo (Contractor Management). The role ensures these systems align with future-state Or

Full-time

USD 183,100.00 - 305,200.00 per year

Senior Validation Engineer

Remote or Durham, North Carolina

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Today

Job Description Summary The Senior Validation Engineer is a subject matter expert in the Commissioning and Qualification program and provides leadership and mentorship in the qualification of equipment, utilities, and processes. Job Description Location: Durham, NC Please note this role is on-site 5 days a week and does not have the ability to work remotely. This role is based in Durham, NC. Novartis is unable to offer relocation support for this role: please only apply if this location is a

Full-time

USD 108,500.00 - 201,500.00 per year

CSV and Validation Engineer

Remote or New Jersey

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Today

Job Description: We are seeking a hands-on CSV and Validation Engineer to validate software used with laboratory instruments and lab informatics platforms. The role owns risk-based validation planning and execution aligned to EMA Annex 11 and 21 CFR Part 11, authors audit-ready documentation, and partners with QA/IT/Lab to transition systems to standardized SOPs. Responsibilities: Plan and execute computer system validation using a risk-based CSA approach aligned to GAMP 5. Validate instrument

Full-time

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21 CFR Part 11 jobs in Phoenix, AZ, USA