IT Manager, Clinical Systems
Summary
IT Manager owns Clinilabs' Corelab clinical systems: overseeing AWS-hosted infrastructure via a service provider, running SDLC/release management and change control for GCP-regulated systems, leading agile/waterfall projects with a software vendor, and ensuring compliance with 21 CFR Part 11, HIPAA, GDPR, and ICH. Remote with occasional travel to the Eatontown, NJ office.
JOB SUMMARY
The Information Technology Manager, Clinical Systems 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.