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 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.
Innovation
- Possesses 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.
- Possesses 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.
Education, Behavioural Competencies and Skills:
- 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.
