IT R&D Technical Lead

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $80 - $90 / hour

⏳ Contract/Temporary

🟠 Senior

🧑‍💻 Full-stack Engineer

🦅 H1B Visa Sponsor

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👻 Ghost score 0%

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PSC Biotech Corporation

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 1996

💼 Consulting

🏥 Healthcare

🧬 Biotechnology

Consulting • Healthcare • Biotechnology

PSC Biotech Corporation is a life science consulting solutions partner that offers a wide range of engineering, technical, and consulting services focused on enhancing operational efficiency, compliance, and quality assurance within the biotech and pharmaceutical sectors. Their expertise includes areas such as auditing, regulatory affairs, commissioning, validation, and project management, helping organizations mitigate risks and streamline processes for successful outcomes in regulated environments.

📋 Description

• 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

• 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

• Health benefits • Paid sick time