Director, Clinical Data Management Operational Delivery

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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

• 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.

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.

ADDITIONAL INFORMATION

• Location: Remote

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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Job Exempt