Senior Manager, Interactive Response Technology, Clinical Trials

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🔥 8 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

👔 Manager

👻 Ghost score 10%

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BioMarin Pharmaceutical Inc.

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1997

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 Post-IPO Debt on 2020-05

Healthcare • Biotechnology • Pharmaceuticals

BioMarin Pharmaceutical Inc. is a leading global biotechnology company dedicated to transforming genetic discoveries into innovative medicines. Founded in 1997, the company has developed eight marketed products that address life-threatening genetic and lysosomal storage disorders such as achondroplasia and severe hemophilia A. BioMarin is also heavily invested in research and development, with a robust pipeline of investigational medicines at various clinical trial stages. The company's mission revolves around improving patient care by leveraging scientific expertise to understand the underlying causes of these conditions. BioMarin is committed to inclusivity and patient advocacy, engaging closely with communities to enhance care and quality of life for those with rare conditions.

📋 Description

• Own the design, build, implementation, and lifecycle management of IRT/RTSM systems across Phase I–IV clinical trials • Manage integrations connecting IRT/RTSM systems to adjacent clinical and enterprise platforms • Serve as project manager for IRT on assigned trials from kickoff through close-out • Translate protocols into User Requirement Specifications covering randomization, visit schedules, dosing regimens, stratification, unblinding, and drug supply configuration • Liaise with external IRT vendors and manage study build timelines, deliverables, and configuration • Develop test plans and lead cross-functional User Acceptance Testing • Coordinate training and system access for site staff, monitors, and study teams • Monitor enrollment and inventory through IRT dashboards and troubleshoot trial issues • Serve as Clinical Supply Chain's single point of contact for IRT activities • Refine IRT resupply parameters to prevent site stock-outs and reduce overages • Manage protocol-amendment changes through formal change control • Lead IRT close-out, including database lock, IRT-to-EDC reconciliation, product accountability, archival, and decommissioning • Maintain IRT/RTSM procedures, work instructions, standards, test scripts, and training materials • Shape the IRT digital roadmap and multi-year capability direction • Lead IRT vendor sourcing, assessments, platform selection, and governance • Serve as the organization's IRT subject matter expert and coach cross-functional teams • Define and report functional KPIs such as system uptime, randomization error rate, stock-outs, and drug wastage • Represent IRT in protocol feasibility, risk management, and digital trial initiatives

🎯 Requirements

• Bachelor's degree in life sciences, engineering, supply chain, information systems, or a related field • Five or more years in clinical supply chain, clinical operations, or clinical systems • At least five years of hands-on IRT or RTSM ownership across multiple concurrent studies • Demonstrated end-to-end delivery of IRT builds, including specification authoring, test leadership, go-live, study operations and support, mid-study change control, and close-out reconciliation • Working knowledge of randomization and blinding methodology, clinical demand forecasting, and IRT resupply algorithms • Proven experience managing external IRT vendors, including timelines, deliverables, quality, and escalation management • Familiarity with GCP, 21 CFR Part 11, computer system validation, and inspection readiness expectations for clinical systems • Ability to work independently across global time zones • Judgment to escalate early and communication skills to align functions that do not report to this role • Hands-on experience with more than one commercial IRT or RTSM platform (preferred) • Rare disease, gene therapy, or global multi-region trial experience (preferred) • Exposure to direct-to-patient supply models, decentralized trials, or adaptive designs (preferred) • Experience with IRT integrations to EDC, CTMS, and ERP or supply planning systems (preferred)

🏖️ Benefits

• Contract engagement for 1 year plus • Full-time temporary employment • Equal employment opportunity protections • Environmental, health, and safety initiatives and training