Clinical Systems IT Manager

The Clinical Systems Information Technology Manager serves as systems owner and technology leader for Corelab information technology clinical systems and applications., * 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.

• 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