About this opportunity
Clinilabs lists this Clinical Systems IT Manager opportunity in northern, Kentucky. Review the employer’s description below for duties, qualifications and application requirements.
Job description
The Clinical Systems Information Technology Manager serves as systems owner and technology leader for Corelab information technology clinical systems and applications.
RESPONSIBILITIES
System owner and technology lead for Corelab business unit systems and applications
Work with Clinilabs AWS provider and internal resources to build and maintain architecture and design documents of Clinilabs clinical systems
Maintain and execute Clinilabs SDLC and release management for GCP regulated clinical systems
Project management, both agile and waterfall, for application development and system design, build implementation, providing direction to Clinilabs software development vendor partner
Operationally oversee Clinilabs AWS service provider to ensure Corelab clinical systems do not run into capacity issues, backups are run, patches are applied and systems always remain recoverable in alignment with Clinilabs DR policy
Adhere to change management procedures, creating change controls for updates to Corelab systems
Prepare and present vendor qualification audit materials to regulatory authorities, sponsors and other customers
Participate in validation activities including requirements gathering, SOP authoring and user acceptance testing
Provide input on development projects and implementing new technology related to Corelab functions or other Clinilabs’ clinical systems in support of clinical studies
Serve as technical resource for internal and external support requests related to Corelab computer and other clinical application systems ensuring timely resolution
Follow and ensure compliance with current regulatory requirements Title CFR 21 Part 11, GCP, HIPAA, GDPR, ICH and other regional regulatory guidance
Perform other related duties as assigned to support IT operations, security, compliance, and business objectives
Salary range between $120,000 - $130,000. Final compensation is based on skills, experience, location, and overall expertise.
TRAVEL
This is a remote position with occasional travel to the Eatontown, NJ office.
Requirements
REQUIRED EDUCATION, KNOWLEDGE, SKILLS AND ABILITIES
This position requires a 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 is required
Must demonstrate competence in both 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
Demonstrated experience working with web hosted applications, SQL, M365, AWS, Linux, DNS, 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 the ability to collaborate effectively with business leaders, application developers, DBAs and vendors to gather and translate business requirements
Requirements gathering and execution of validation deliverables in a GCP environment
History of work in a regulated GxP, life sciences, pharmaceutical, or related environment is highly preferred and will be considered a strong differentiator for qualified candidates
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Who can apply
Review the original listing for work authorization, qualifications and employer requirements.