Note: The job is a remote job and is open to candidates in USA. Takeda Pharmaceutical is a pharmaceutical company seeking an Associate Director, RBQM Data Enablement and Analytics. The role is responsible for configuring and managing Risk-Based Quality Management technology, data flows, platform operations, and analytics to identify critical study risks and improve clinical trial execution. The position also provides subject matter expertise, supports cross-functional teams and vendors, and drives continuous process and capability enhancements.
Responsibilities
- Configure Centralized Monitoring platform, including DQA, QTLs and KRIs, to identify and manage critical study risks
- Translate Study Risk Assessments into system specifications and configure RBQM technology accordingly
- Identifies and shares best practices, successes, case studies, failures, and process improvement opportunities to promote continuous improvement and consistency with RBQM processes
- Acts as a change agent, champion, subject matter expert and point of contact of RBQM methodology, leading study teams to understand and follow the best practices to achieve maximum benefit
- May perform line management of other staff within RBQM Data Enablement
- Manage and optimize RBQM dataflows across study, program, and enterprise systems
- Contributes to the creation of a lessons learned framework to ensure insights from RBQM activities are captured and applied to future studies with similar characteristics
- Manage RBQM platform operations, including user access and system governance
- Drive continuous enhancement of RBQM Data Enablement processes, tools, and capabilities
- Develop training materials and deliver internal/external training on RBQM solutions as needed
- Partner with RBQM Operations, Business Systems, R&D IT, TIDE and vendors to support technology releases and data enablement
- Assist RBQM Operations and study team with the investigation and explanation of complex Central Monitoring signals and outputs
- Serve as Subject Matter Expert for RBQM technology, data flows, documentation, inspections, audits, and complex signal interpretation as needed
- Identify novel ways to implement RBQM data enablement capabilities across the data continuum to drive operational efficiencies at the clinical trial level in partnership with RBQM Operations
- Serve as primary point of contact for cross-functional escalation and issue management triage for Data Enablement
- Oversee strategic vendor and partner ecosystem in partnership with GDO Business Operations, including FSPs, CROs, and technology providers, setting performance expectations, governing delivery, and ensuring alignment to RBQM operating principles and outcomes
Skills
- Minimum of 8 years of experience in the pharmaceutical or CRO industry
- Minimum of 3 years of experience in Risk Based Quality Management
- Minimum of 2 years managerial and supervisory experience
- Robust understanding of the drug development process and clinical trial execution
- Knowledge of industry regulatory standards including 21 CFR Part 11, ICH E6, ICH E8 (GCP)
- Experience in risk management, sponsor audits and health authority inspections, root cause analyses and mitigation strategies as well as Corrective Actions Preventive Actions
- Knowledge of RBQM IT systems or other data analytic systems
- Demonstrated ability to analyze data, identify patterns and make recommendations for improvement
- Demonstrated ability to effectively lead cross functional team meetings
- Experience forming cross-functional collaborations; strong interpersonal skills
- Supports a culture of continual improvement and innovation; promotes knowledge sharing
- Ability to influence without authority and effectively communicate cross functionally with people of various levels
- Thinks creatively; challenges the status quo
- Thinks strategically, adopts breakthrough ideas
- Encourages open dialogue
- Takes decisive action and can prioritize
- Proactively takes steps to learn and grow
- Pragmatic and willing to drive and support change
- Comfortable with ambiguity
- Excellent teamwork, organizational, interpersonal, and problem-solving skills
- Assertive and collaborative communication style
- Attention to detail and a critical thinker
- Embraces and demonstrates a diversity and inclusion mindset and sets an example for these behaviors for the organization
Company Overview
Company H1B Sponsorship