Senior Manager, Interactive Response Technology, Clinical Trials

BioMarin Pharmaceutical Inc.

. Own the design, build, implementation, and lifecycle management of IRT/RTSM systems across Phase I–IV clinical trials .

Posted 9/30/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in IRT/RTSM system design, implementation, and lifecycle management across clinical trials, with a strong focus on project management, vendor relations, and compliance with regulatory standards. Proficient in translating clinical protocols into user requirements and managing integrations with clinical and enterprise platforms.

Highest-signal resume keywords

IRT/RTSM System OwnershipClinical Supply Chain ManagementUser Requirement Specification DevelopmentVendor ManagementGCP Compliance

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

IRT/RTSM System DesignRandomization MethodologyClinical Demand ForecastingTest Plan DevelopmentChange Control ManagementDatabase Lock ProceduresUser Acceptance TestingSpecification AuthoringInventory MonitoringProtocol Amendment Management

Soft Skills

Project ManagementCommunication SkillsJudgmentCross-Functional CollaborationProblem-Solving

Tools & Technologies

IRT PlatformsEDC SystemsCTMSERP SystemsDashboards

Industry Keywords

Clinical TrialsLife SciencesRegulatory ComplianceDecentralized TrialsRare DiseaseGene TherapyAdaptive DesignsInspection ReadinessComputer System ValidationGlobal Multi-Region Trials

Tech Stack

Tools & technologies

ERPGoogle Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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