IT R&D Technical Lead

PSC Biotech; Northern (KY); On-site; USD 110,000 - 124,000; Full time

Benefits offered by this job

Health benefits

Paid sick time

Job summary

PSC Biotech in the United States seeks an 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.

This role blends hands-on technical depth with business analysis and production support in a GxP-regulated environment. 7+ years in clinical R&D IT, with Veeva Vault Vault Ops modules (eTMF, CTMS, Payments) preferred; US work authorization is

Qualifications

• Bachelor's degree in IT or related field.
• 7+ years of experience in clinical R&D IT systems.
• Hands-on with Veeva Vault Clinical Operations suite (eTMF, CTMS, Payments).

Responsibilities

• Serve as the go-to system owner for clinical operations, shaping the systems roadmap.
• Assess requests, prioritize backlog, and plan sprints with IT leadership.
• Lead end-to-end deployments and coordinate with vendors.
• Ensure compliance with GxP, HIPAA, GDPR, and CCPA.

Skills

Regulatory compliance

Analytical thinking

Independent worker

Stakeholder communication

Education

Bachelor's degree in Information Technology or related field

Tools

Veeva Vault

Veeva Vault eTMF

Veeva CTMS

Veeva Payments

Job description

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.

This is a W2 Temp Contract position, starting at the 3-month duration with potential extension. Candidates must be authorized to work in the United States.We are unable to consider Corp-to-Corp (C2C) arrangements at this time.

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.
  

Requirements

• 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.

W2 Temp positions include health benefits and paid sick time.

Adhering to the requirements of U.S laws on salary transparency, the base annual salary range expected for this role is set between $80 - $90/hour. The salary offered may be adjusted based on various factors such as the applicant's qualifications, skills, and professional experience.

Equal Opportunity Employment Statement

PSC Biotech is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.