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IT R&D Technical Lead
PSC Biotech Corporation. Partner with clinical operations stakeholders as their go-to system owner, understanding their goals, pain points and priorities .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical R&D information systems, with a strong focus on Veeva Vault Clinical Operations suite and compliance with GxP, HIPAA, GDPR, and CCPA regulations. Capable of leading technical evaluations, designing solutions, and overseeing project execution from functional and technical perspectives.
Highest-signal resume keywords
Veeva Vault Clinical Operations SuiteGxP ComplianceClinical R&D Information SystemsAPI-Based IntegrationsIT Change Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Systems Roadmap ManagementData MappingSystem Integration DesignRequirements-Based TestingTechnical Specifications EvaluationVendor ManagementSprint PlanningSoftware Defect EscalationValidation Logic DesignRegulated SDLC Delivery
Soft Skills
Analytical SkillsTroubleshooting SkillsIndependent WorkPrioritizationIssue Resolution
Tools & Technologies
Veeva EDC (CDMS)WCG TrifectaIRT/IxRSEDiary/eCOAITSM
Certifications & Qualifications
Veeva Vault Owner Training or Certification
Industry Keywords
Pharmaceutical IndustryBiotech IndustryCRO IndustryGCP-Regulated SystemsComputer System Validation
Tech Stack
Tools & technologiesGoogle Cloud PlatformITSMSDLCVault
About the role
Key responsibilities & impact- Partner with clinical operations stakeholders as their go-to system owner, understanding their goals, pain points and priorities
- Shape and maintain the clinical systems roadmap by gathering demand, aligning priorities with R&D IT leadership and communicating progress
- Act as the technical subject matter expert for maintenance and enhancement activities
- Assess incoming requests, shape solutions and organize the backlog for sprint planning
- Evaluate technical specifications and vendor-proposed solutions for scalability, performance and maintainability
- Oversee projects end to end from functional and technical perspectives
- Escalate software vendor defects and issues
- Coordinate deployments, identify dependencies, approve release plans, manage IT change requests and oversee go-lives
- Design and deliver system integrations with business and data management partners
- Define data mappings and endpoint requirements
- Set validation and insert/upsert logic
- Assess publish versus subscribe integration patterns
- Lead requirements walkthroughs and technical reviews with vendors
- Support testing in production and non-production environments
- Ensure work follows GxP, HIPAA, GDPR and CCPA requirements
Requirements
What you’ll need- Bachelor's degree in Information Technology, Computer Science, Information Systems or a related field
- 7+ years of experience supporting clinical R&D information systems in the pharmaceutical, biotech or CRO industry
- Hands-on experience with the Veeva Vault Clinical Operations suite, specifically eTMF, CTMS and Payments
- Experience with Veeva Vault Owner training or certification strongly preferred
- Experience with Veeva EDC (CDMS), WCG Trifecta, IRT/IxRS, eDiary/eCOA is a plus
- Solid understanding of GCP-regulated systems, computer system validation and requirements-based testing
- Experience delivering within a regulated SDLC, including API-based integrations
- Working knowledge of ITSM and IT change management processes
- Ability to design solutions at a technical level and critically evaluate vendor recommendations
- Strong analytical and troubleshooting skills
- Ability to work independently, set priorities and drive issues to resolution
- Must be authorized to work in the U.S.
- No C2C at this time
Benefits
Comp & perks- Health benefits
- Paid sick time