Associate Director, RBQM Data Enablement and Analytics

Takeda; United States; On-site; USD 180,000 - 230,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior RBQM Data Enablement Lead to configure Centralized Monitoring platforms, translate risk assessments into system specs, and drive RBQM process improvements. You will oversee data flows, support releases, manage vendors, and serve as the RBQM technology SME.

Requirements include 8+ years in pharma/CRO, 3+ years RBQM, and 2+ years managerial experience; regulatory compliance knowledge (21 CFR Part 11, ICH E6) is essential.

Qualifications

• Must have RBQM expertise and strong risk assessment interpretation.

Responsibilities

• Configure and manage Centralized Monitoring platforms.
• Translate risk assessments into system specifications for RBQM.
• Drive continuous process improvements in Risk Based Quality Management.

Skills

Risk management

Data analytics

Cross-functional leadership

RBQM IT systems

Job description

Role: Senior RBQM Data Enablement Lead responsible for configuring and managing Centralized Monitoring platforms, translating risk assessments into system specifications, and driving continuous process improvements in Risk Based Quality Management (RBQM) within clinical trials.

Responsibilities include overseeing data flows across systems, supporting technology releases, managing vendor relationships, and serving as subject matter expert on RBQM technology and signal interpretation.

Requirements: minimum 8 years in pharma or CRO, at least 3 years in RBQM, and 2+ years of managerial experience; strong understanding of drug development, GxP standards, and regulatory compliance (e.g., 21 CFR Part 11, ICH E6).

Preferred skills include expertise in risk management, data analytics, and cross-functional leadership, with proficiency in RBQM IT systems.

High-Value: focus on clinical trial data enablement, risk-based monitoring, and technology governance; virtual work setup in Massachusetts with no travel specified.