IT System Owner

Job DescriptionJob Description

The IT R&D Contractor will support maintenance and enhancement of IT R&D systems.  The ideal candidate will be well versed in ITSM and IT Change Management, have technical experience in managing IT R&D Systems as well as experience in Business Analysis, Project Management, Release Management and Production Support of hosted and SaaS IT R&D systems.

Responsibilities:

• Serve as a trusted IT System Owner to the Global Clinical Operations business units by clearly understanding their objectives, challenges, and opportunities.
• Work with the ITR&D lead to establish and maintain IT Roadmaps by aligning with business teams on new demand, provide updates on existing projects.
• Lead System Maintenance and Enhancement (M&E) as a technical SME, understand new M&E requests from the business, perform impact assessment on existing functionality and design and prioritize new requests for sprint planning.
• Prioritize new requests for sprint planning.  Review technical specifications and design and provide technical feedback to ensure solution is scalable and optimal.
• Oversee entire life cycle of implementation from a functional and technical standpoint and work with vendor to resolve issues
• Collaborate with BSO and project team on roll-out planning by understanding dependencies, approving the release plan, managing the IT Change Request, and driving the overall implementation process.
• Deliver technical integrations by collaborating with business and IT data management teams. Own and drive data mapping requirements, technical requirements for integration endpoints, data validation, rules for insert/upsert and evaluation of publishing vs. subscription models.
• Work with vendors to perform requirements walkthrough, technical reviews, testing in Production and non-Production environments.
• Perform all activities in compliance with relevant requirements/standards and controls (e.g., GxP, HIPAA, GDPR, CCPA).

Requirements / Qualifications:

• Bachelor’s degree in Information Technology, Computer Systems, Information Systems or related field from a 4-year accredited institution.
• 7+ years of relevant experience working with Clinical IT R&D systems. Hands-on experience with the following systems is required:  Veeva platform specifically eTMF, CTMS, Payments, IRT/IxRS, eDiary.
• Hands-on experience with Veeva Vault RIM - Registrations, Submissions, Submissions Archive and Publishing is desired
• Veeva certified Vault owner training and experience is highly recommended.
• Ability to provide solutions at a technical level and review technical solutions recommended by vendors.
• Experience with one or more of the following systems is preferred: Imaging systems, Wearables, eConsent, EDC, Drug Safety, Grant Management systems etc.
• Strong knowledge of GxP systems and their requirements. Experience with testing applications based on requirements needed.
• Ability to provide solutions at a technical level and review technical solutions recommended by vendors.
• Experience with System Development Lifecycle (SDLC) in a regulated environment including integrations using APIs
• Excellent analytical skills for requirements analysis and proven ability to troubleshoot issues independently and prioritize steps in delivering solutions. 

Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.Company DescriptionThe Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.

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