Veeva eTMF/CTMS Configuration

 

Position 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 include, but are not limited to: 

 

• Serve as a trusted IT System Owner to the Global Clinical Operations business units by clearly understanding their objectives, challenges, and opportunities.  
• Sold understanding of CTMS object model, key objects, workflows and functional processes in Clinical space.

• 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). 

 

• Technical Requirements & Skills:  

• 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.

• 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: Veeva EDC, WCG Trifecta, IRT/IxRS, eDiary

• Strong knowledge of Google Cloud Platform 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