Director, Clinical Data Management Operational Delivery
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Director, Clinical Data Management Operational Delivery based remotely reporting to the Vice President, Head of Clinical Data Operations and Standards.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to work towards their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
Here, you will be a necessary contributor to our inspiring, bold mission.
GOALS:
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 excellent 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
Functional Service Provider (FSP) :
- 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.
In-Direct line management:
- 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 internal
