> Markdown version of [/jobs/ext/1227027-director-clinical-data-management-operational-delivery](https://www.wearedevelopers.com/jobs/ext/1227027-director-clinical-data-management-operational-delivery). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Director, Clinical Data Management Operational Delivery - **Company:** Takeda Pharmaceutical Company Limited - **Location:** United States (Remote available) - **Experience:** Expert - **Salary:** $177,000.0 - $278,080.0 - **Contract:** Franchise - **Skills:** Clinical Data Management, Databases, Data Warehousing, Relational Databases, Electronic Data Capture, Data Processing, Data Management - **Published:** July 10, 2026 - **Apply:** https://takeda.wd3.myworkdayjobs.com/External/job/Massachusetts---Virtual/Director--Clinical-Data-Management-Operational-Delivery_R0184194/apply ## About the Role * Posseses a visionary and forward thinking mindset with the ability to influence and effectively drive organizational change and continuous innovation. * Promotes automation, innovation, process improvement and technology enhancement in DM to increase Drug Development efficiency. Complexity * Ability to work in a global ecosystem (internal and external) with a high degree of complexity. * Posesses a breadth of knowledge across therapeutic areas, indications, and/or modalities. * Domestic/international travel (5-20%) to other Takeda sites, strategic partners, and therapeutic area events may be required., * Bachelor's/MS Degree or international equivalent preferred, or equivalent combination of education, training and experience 10+ years of data management experience in the pharmaceutical industry. * Expert knowledge and successful experience managing vendor relationships and alliance partnerships with at least 7 years experience in this area. * Excellent verbal/written communication skills and ability to influence at all levels across functions and build effective relationships. * Seasoned leader with a passion for people development and an ability perform in a highly dynamic environment. * Exceptional interpersonal skills, outstanding negotiation and problem solving skills. * Focused and versatile leader who excels under pressure, ambiguity, frequent change, or unpredictability. * Entrepreneurial and innovative; takes measured risks; thinks outside the box; challenge the status quo. * 5+ years of line management experience (prior second-level management experience preferred). * Expert knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process. * Experience with budget planning. * Strong knowledge of relational databases and experience using multiple clinical data management systems. * Strong knowledge of electronic data capture and data warehouse technologies as applied to clinical trials. * Advanced knowledge of broad drug development process with expertise in the cross- functional interfaces with the data management function. ## 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 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 internalize key CDM capabilities. Responsibilities may include: * 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 and enterprise view for study deliverable risks for Takeda. * Provides mechanism for oversight and reporting out 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 tools + Ensuring processes are in place (e.g., Data processing, coding, reconciliation) + Accountable for oversight of deliverable readouts and guidance for the CDM program leads on capturing risk and mitigation collection and management * Oversee CDM inspection readiness within assigned asset and/or therapeutic area(s). * Represents function in external professional initiatives and organizations (e.g., SCDM, CDISC, DIA) to identify industry best practice and increase the visibility of Takeda. * Identifies, recommends and drives changes in industry best practices and/or regulatory trends within and across TAUs. * Other duties as assigned. DIMENSIONS AND ASPECTS Technical/Functional (Line) Expertise * Participates in the evaluation and selection of new technologies to drive innovative and efficient working practices for DM that enable high quality delivery. * Implements best practices for CDM processes that are aligned with industry and evolving regulatory expectations. Leadership * Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing. * Champions Risk Based approaches to DM processes, such as cleaning and review of data. * Provides oversight and leads the efforts to implement and develop DM processes and tools based on emerging trends, technology, and best practices. * Ability to influence a Global Workforce and Talent strategy for colleagues in the Global, Regional and Local organizations. * Ability to distill complex issues and ideas down to simple comprehensible terms. * Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization. Decision-making and Autonomy * Ability to make highly complex decisions that impact the enterprise. * Accountable for operational decision making for designated area of responsibility as well as aligning across TAUs to ensure consistency within the functional area. * Ability to seek diverse input from stakeholders to lead and drive innovative solutions. * Seek diverse input from multiple stakeholders to help drive innovative solutions. * Incorporate feedback and ensure decisions are made swiftly to yield flawless execution. Interaction * Effectively represent Takeda in High-level negotiations with the ability to resolve conflict in a constructive manner. ## Related Videos - [It's all about the Data](https://www.wearedevelopers.com/videos/425-it-s-all-about-the-data) - [Kubernetes and Microservices with Multi-Model Databases](https://www.wearedevelopers.com/videos/382-kubernetes-and-microservices-with-multi-model-databases) - [Implementing continuous delivery in a data processing pipeline](https://www.wearedevelopers.com/videos/73-implementing-continuous-delivery-in-a-data-processing-pipeline) - [Blueprints for Success: Steering a Global Data & AI Architecture](https://www.wearedevelopers.com/videos/1577-blueprints-for-success-steering-a-global-data-ai-architecture) - [Databaseless Data Processing - High-Performance for Cloud-Native Apps and AI](https://www.wearedevelopers.com/videos/1024-databaseless-data-processing-high-performance-for-cloud-native-apps-and-ai) - [The Data Mesh as the end of the Datalake as we know it](https://www.wearedevelopers.com/videos/156-the-data-mesh-as-the-end-of-the-datalake-as-we-know-it) ## Related Articles - [Coffee with Developers - Maria Apazoglou - Making AI understandable for all in production](https://www.wearedevelopers.com/magazine/475-coffee-with-developers-maria-apazoglou-making-ai-understandable-for-all-in-production) - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers) - [The Biggest German Tech Companies](https://www.wearedevelopers.com/magazine/424-the-biggest-german-tech-companies) - [From developer to manager – what does it take to become an engineering manager?](https://www.wearedevelopers.com/magazine/42-from-developer-to-manager-what-does-it-take-to-become-an-engineering-manager) - [Should Tech Managers Be Developers First? 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