Clinical Systems IT Manager

Jobtailor; Eatontown (NJ); On-site; USD 140,000 - 180,000; Full time

Job summary

Clinilabs is seeking a systems owner and technology leader for Corelab information technology clinical systems in a New Jersey setting. You will work with Clinilabs' AWS provider and internal teams to build architecture and design documents, and oversee SDLC and release management for GCP-regulated clinical systems.

You will manage agile and waterfall projects, lead vendor partners, ensure change controls, and maintain compliance with CFR 21 Part 11, GCP, HIPAA, and GDPR across validation

Qualifications

• Bachelor’s degree in computer science, information systems or a related field. Extensive experience may be considered in lieu of degree.
• Seven years of IT engineering and data management in life sciences or CRO.
• Three years of IT management leading internal resources and vendors.
• Experience with waterfall and Agile project management, including planning, execution and delivery oversight.
• Experience managing data acquisition systems, transfer protocols and data lifecycle management.
• Experience with web hosted applications, SQL, AWS, Linux, DNS, and CDN technologies with data management systems.
• Strong knowledge of SDLC processes and software application architecture.
• Experience in regulated GxP environments (GCP, CFR 21 Part 11) is highly preferred.

Responsibilities

• Serve as systems owner and technology leader for Corelab information technology clinical systems.
• Collaborate with Clinilabs AWS provider and internal teams to build architecture and design docs.
• Oversee SDLC and release management for GCP-regulated clinical systems.
• Manage agile and waterfall projects for development, design, build and implementation.
• Provide direction to Clinilabs software development vendor partners.
• Ensure compliance with CFR 21 Part 11, GCP, HIPAA, GDPR and related regulations.

Skills

IT Engineering

Data Management

Software Architecture

Requirements Gathering

Validation Deliverables

SDLC

Leadership

Education

Bachelor’s degree in computer science, information systems or related field

Tools

AWS

GCP

SQL

M365

Linux

DNS

CDN Technologies

Job description

• Serve as systems owner and technology leader for Corelab information technology clinical systems and applications
• Work with Clinilabs AWS provider and internal resources to build and maintain architecture and design documents
• Maintain and execute Clinilabs SDLC and release management for GCP regulated clinical systems
• Manage agile and waterfall projects for application development and system design, build, and implementation
• Provide direction to Clinilabs software development vendor partner
• Operationally oversee Clinilabs AWS service provider, including capacity, backups, patching, and recoverability in alignment with DR policy
• Adhere to change management procedures and create change controls for Corelab systems
• Prepare and present vendor qualification audit materials to regulatory authorities, sponsors, and customers
• Participate in validation activities, including requirements gathering, SOP authoring, and user acceptance testing
• Support development projects and implementation of technology related to Corelab functions and clinical systems
• Serve as technical resource for internal and external support requests and ensure timely resolution
• Ensure compliance with CFR 21 Part 11, GCP, HIPAA, GDPR, ICH, and other regional regulatory guidance
• Perform related duties supporting IT operations, security, compliance, and business objectives

Requirements

• Bachelor’s degree in computer science, information systems or a related field; extensive relevant experience may be considered in lieu of a degree
• Seven years of experience in information technology engineering and data management within a life sciences or contract research organization
• Three years’ IT management experience leading internal resources and vendors
• Leadership experience in software application design, implementation and operations
• Competence in waterfall and agile project management methodologies, including planning, execution, stakeholder communication, and delivery oversight
• Experience managing data acquisition systems, transfer protocols and data lifecycle management
• Experience working with web hosted applications, SQL, M365, AWS, Linux, DNS, and CDN technologies with data management systems
• Comprehensive knowledge of software development life cycle (SDLC) processes
• Strong understanding of software application architecture, including component design, application interactions, backend server configuration, and ongoing system management
• Excellent interpersonal and communication skills, with ability to collaborate with business leaders, application developers, DBAs and vendors
• Experience gathering requirements and executing validation deliverables in a GCP environment
• History of work in a regulated GxP, life sciences, pharmaceutical, or related environment highly preferred

Core Competencies

Demonstrates expertise in managing clinical information technology systems, including leadership in software application design, implementation, and compliance with regulatory standards such as GCP and CFR 21 Part 11. Proficient in project management methodologies, both agile and waterfall, with a strong focus on data management and system architecture.

Highest-signal resume keywords

• Clinical Systems Management
• Software Development Life Cycle (SDLC)
• Agile and Waterfall Project Management
• Regulatory Compliance (GCP, CFR 21 Part 11)
• Data Management Systems

Hard Skills

• Information Technology Engineering
• Data Management
• Software Application Design
• Requirements Gathering
• Validation Deliverables
• System Architecture
• Capacity Management
• Change Management Procedures
• User Acceptance Testing
• Data Lifecycle Management

Soft Skills

• Interpersonal Skills
• Communication Skills
• Collaboration

Industry Keywords

• Life Sciences
• Contract Research Organization
• GxP
• Pharmaceutical

Tools & Technologies

• AWS
• GCP
• SQL
• M365
• Linux
• DNS
• CDN Technologies