[Hiring] IT R&D Technical Lead @PSC Biotech

Role Description

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.

Qualifications

• 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.

Benefits

• W2 Temp positions include health benefits and paid sick time.
• 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.