Director, Clinical Data Management Operational Delivery

Job Description

Lead global implementation and adoption of new/enhanced Clinical Data Management (CDM) processes, ways of working, and technology (e.g., CFDR), while providing enterprise-level oversight of data management (DM) delivery, study timelines standardization, and inspection readiness across assigned assets/TAUs/portfolios.

• The Director will be expected to lead implementation of new and enhanced processes, new ways of working and technology implementation projects (e.g., CFDR) within clinical data management (CDM), including:
  • Lead oversight and partner across CDSO and CDOS to ensure roll out.
  • Identify risks and work with CDM LT and other Cross Function leaders to mitigate.
  • Coordinate with CDM LT to set initiative priorities.
  • Partner with Global Development Compliance (GDC) to implement and monitor rollout of new processes, tech, and ways of working.
• Champions harmonization, change management and user adoption efforts across regions, TAUs and service providers.
• Serve as Functional Process Owner and Expert (FPE) in Takeda's continuous improvement framework:
  • Partner with process Business Process Owner (BPO), GDC, and BSO to ensure controlled and business-controlled process documents are complete, meet regulatory compliance (as applicable), and are optimized for end user needs.
• Lead champion/SME network (e.g., CFDR) to embed process and tech knowledge & proficiency in CDM functional members.
• Lead and/or participate in process excellence and/or initiatives through operational implementation.
• Partner across TAUs and roles to ensure consistent approach and implementation of process and ways of working.
• Serve as lead CDM standards governance representative.
• Serve as lead CDM stakeholder and partner with BSO to ensure technology aligns with CDM roadmap.
• The Director is responsible for effective leadership of setting up framework for tracking project timeline deliverables at an enterprise level for DM activities globally within and across a key asset, franchise/portfolio and/or therapeutic area(s).
• Provides enterprise view of study timelines and status across the study lifecycle for DM end to end tasks from start-up through database lock at the TAU, program(s), and/or portfolio level.
• Develop and maintain FTE and/or FSP Resourcing model and algorithm in alignment with CDM TAU LT and ensure consistent implementation across TAU according to the CDM vision.
• Drives significant levels of business change, within CDM and across the broader organization to ensure the successful execution of the CDM strategy and operating models.
• Provides DM expertise in support of CDM operating model for TAU, program(s), and/or portfolio level.
• Develop and maintain CFDR stakeholder management across SET roles to support operational excellence and escalation activities.
• Provide expert functional support guidance in audit readiness.

• The Director may have direct line management responsibilities and/or supervisory responsibility for global FSPs.
• Responsible for oversight of FSP resource allocation and DM strategic vendor partnerships to effectively deliver on internal and/or outsourced projects.

• Relationship manager, establishing and maintaining productive partnerships within Clinical Data Management (CDM), functional leaders across R&D, and third‑party service providers.
• Champions CDM operational excellence by leading and developing flexible, scalable and innovative methods to internalize key CDM capabilities.

• Establish and maintain a framework for CDM Project Management to enable CDM LT and leads oversight for data management delivery across all global development programs within assigned asset and/or therapeutic area(s).
• Establish a mechanism for enterprise view for study deliverable risks for Takeda.
• Provides mechanism for oversight and reporting of achievement of major DM deliverables and milestones in coordination with other functions including the Therapeutic Area Units, Clinical Operations, Pharmacovigilance and Statistics:
  • Provides DM knowledge in CDM activities, including but not limited to the design and implementation of data capture…