Manager, IRT Operations
Teva Pharmaceuticals · West Chester, PA · 4 wk ago
OTHRFull-time
About the role
Join Teva's Clinical Supply & Logistics team as the functional and technical owner of the Interactive Response Technology (IRT/RTSM) systems for new and ongoing clinical studies. You’ll lead setup and lifecycle management, set standards across IRT vendor partners, and ensure randomization and clinical‑supply workflows are compliant, reliable, and inspection‑ready—helping bring medicines to patients faster.
Responsibilities
- Translate protocols and supply strategies into IRT/RTSM requirements and design.
- Lead configuration, UAT, release, maintenance, and close‑out with external IRT vendors.
- Establish consistent standards and best practices across multiple IRT vendors.
- Manage vendor performance, service levels, change requests, and issue resolution.
- Track KPIs and own change control and Audit Trail Reviews.
- Ensure data integrity across IRT, EDC, forecasting tools, and inventory systems, and act as primary IRT contact during audits and inspections.
Requirements
- 5+ years in pharma/biotech clinical operations or clinical supply chain, with 3+ years of hands‑on IRT/RTSM ownership.
- Experience with major IRT platforms and external vendor management.
- Strong knowledge of randomization, drug supply strategies, ICH E6, GCP, CSV, and GxP data integrity.
- Excellent communication and cross‑functional collaboration skills.
- Bachelor’s degree in Life Sciences, Engineering, Computer Science, or a related field.
Preferred qualifications
- Global, multi‑country Phase II–III trial experience and complex trial designs.
- Experience with IRT integrations to EDC/CTMS/inventory systems.
- Familiarity with risk‑based quality management and KPI dashboards.
- Familiarity with Power BI and AI tools.
Benefits
- Generous annual leave and reward plans.
- Flexible working schedules (dependent on role).
- Access to tailored health support and wellness resources.
- Opportunities to give back to the community.
- Career development platform “Twist” offering learning programs, short‑term projects, and internal growth pathways.
- A culture that empowers you to reach your goals and prioritize wellbeing.