IT R&D Technical Lead

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with clinical operations stakeholders as their primary system owner, gaining insights into their objectives, challenges, and priorities.

• Develop and sustain the clinical systems roadmap by collecting demand, aligning priorities with R&D IT leadership, and communicating updates.

• Serve as the technical subject matter expert for maintenance and enhancement initiatives.

• Evaluate incoming requests, formulate solutions, and organize the backlog for sprint planning.

• Review technical specifications and vendor-proposed solutions for scalability, performance, and maintainability.

• Manage projects from initiation to completion from both functional and technical viewpoints.

• Address software vendor defects and issues through escalation.

• Coordinate deployments, identify dependencies, approve release plans, manage IT change requests, and oversee go-live activities.

• Design and implement system integrations with business and data management partners.

• Define data mappings and endpoint requirements.

• Establish validation and insert/upsert logic.

• Evaluate publish versus subscribe integration patterns.

• Lead requirements walkthroughs and technical reviews with vendors.

• Assist in testing within both production and non-production environments.

• Ensure compliance with GxP, HIPAA, GDPR, and CCPA requirements.

⛳️ Requirements

• Bachelor's degree in Information Technology, Computer Science, Information Systems, or a related discipline.

• Over 7 years of experience supporting clinical R&D information systems in the pharmaceutical, biotech, or CRO sectors.

• Practical experience with the Veeva Vault Clinical Operations suite, particularly eTMF, CTMS, and Payments.

• Veeva Vault Owner training or certification is highly desirable.

• Familiarity with Veeva EDC (CDMS), WCG Trifecta, IRT/IxRS, eDiary/eCOA is advantageous.

• Strong understanding of GCP-regulated systems, computer system validation, and requirements-based testing.

• Proven track record of delivering within a regulated SDLC, including API-based integrations.

• Working knowledge of ITSM and IT change management processes.

• Capability to design solutions at a technical level and critically assess vendor recommendations.

• Excellent analytical and troubleshooting abilities.

• Aptitude to work independently, prioritize tasks, and drive issues to resolution.

• Must be authorized to work in the U.S.

• No C2C arrangements at this time.

🏝️ Benefits

• Health benefits

• Paid sick time