IT R&D Contractor

Summary:

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:

·        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.