IT R&D Technical Lead

This is a remote position.

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech® is passionate about bringing the best and brightest together in an effort to form something truly special. When you decide to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech®, it's about more than just a job—it's about your career and your future.

Your Role

We are hiring an experienced IT R&D Clinical Systems Owner to lead the ongoing support, optimization and growth of a Veeva Vault Clinical platform. You will be the main technical and functional contact for clinical operations stakeholders. You will turn business needs into well-designed system enhancements and guide each change from intake through validated release. The role suits someone who combines hands-on technical depth with business analysis, delivery management and production support in a GxP-regulated environment.

What You'll Do

• Partner with clinical operations stakeholders as their go-to system owner, building a deep understanding of their goals, pain points and priorities.
  
• Help shape and maintain the clinical systems roadmap by gathering new demand, aligning priorities with R&D IT leadership and communicating progress on active initiatives.
  
• Act as the technical subject matter expert for maintenance and enhancement activities. Assess incoming requests for impact on current functionality, shape the solution and organize the backlog for sprint planning.
  
• Evaluate technical specifications and designs, including vendor-proposed solutions, and recommend improvements for scalability, performance and long-term maintainability.
  
• Oversee projects end to end from both a functional and technical perspective. Act as the escalation point with software vendors to resolve defects and issues.
  
• Coordinate deployments with business owners and project teams. Identify dependencies, approve release plans, create and manage IT change requests, and see go-lives through to completion.
  
• Design and deliver system integrations together with business and data management partners. This includes:
  • defining data mappings and endpoint requirements
    
  • setting validation and insert/upsert logic
    
  • assessing publish vs. subscribe integration patterns
    
• Lead requirements walkthroughs and technical reviews with vendors, and support testing in both production and non-production environments.
  
• Make sure all work follows applicable regulatory, quality and privacy requirements, including GxP, HIPAA, GDPR and CCPA.
  

• 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.
  
• Required: hands-on experience with the Veeva Vault Clinical Operations suite, specifically eTMF, CTMS and Payments.
  
• Strongly preferred: Veeva Vault Owner training or certification.
  
• Experience with at least one of the following is a plus: Veeva EDC (CDMS), WCG Trifecta, IRT/IxRS, eDiary/eCOA.
  
• 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.
  
• The ability to design solutions at a technical level and to critically evaluate vendor recommendations.
  
• Strong analytical and troubleshooting skills. You can work independently, set priorities and drive issues to resolution.
  
• Must be authorized to work in the U.S.
  
• No C2C at this time.