Note: The job is a remote job and is open to candidates in USA. Takeda is a patient-focused, innovation-driven company transforming the pharmaceutical industry. The Associate Director, Clinical Data Configuration will lead clinical data configuration activities and coordinate cross-functional teams to ensure high-quality deliverables that support clinical trials.
Responsibilities
- Lead and develop a team of Data Configuration Representatives, setting priorities, allocating resources, and driving accountable delivery of data configuration and transformation capabilities that enable clinical trial execution across programs
- Direct cross-functional/matrix teams and vendor delivery across data configuration, transformation, and visualization platforms; own timelines, quality, and outcomes while ensuring alignment to enterprise data strategy and clinical program needs
- Own stakeholder engagement with data engineering and clinical partners to define requirements, influence solution design, and ensure scalable, reusable data transformation and visualization capabilities across the portfolio
- Provide end-to-end program leadership for data configuration and transformation initiatives, translating strategic priorities into executable plans and driving delivery across multiple concurrent programs in a complex, matrixed environment
- Define, govern and promote standards, best practices, and data transfer specifications; own SOP development, implementation, and continuous improvement to ensure consistency, scalability, and compliance across platforms
- Establish and enforce quality frameworks for internally delivered and vendor-supported outputs, ensuring data integrity, compliance, and adherence to enterprise standards across all deliverables
- Own inspection readiness for data configuration and transformation activities, ensuring audit‑ready processes, documentation, and controls that meet regulatory expectations and minimize organizational risk
Skills
- Bachelor's degree (e.g., CS, statistics/biostatistics, math, biology/health-related) plus minimum 7 years relevant experience (or equivalent)
- Experience with EDC build/data management or EDC extraction/configuration; strong understanding of clinical data flow (CDMS, vendor devices, CDR)
- Familiarity with data cleaning tools (e.g. Veeva CDB, J Review, Elluminate)
- Visualization/configuration: experience designing visual objects and libraries; programming clinical trial visualization tools
- Strong clinical trial terminology and data transfer specification knowledge; understanding of SDTM
- Tools/Ways of Working: Microsoft Office
- Proven project leadership and project management skills including: Initiative, deadline management, strong attention to detail, organization, time management; quick learner comfortable with new tech/systems; able to prioritize competing demands in a fast-paced environment
- Demonstrated ability to lead projects/workgroups
- Demonstrated ability to resolve issues independently and collaboratively; takes initiative; delivers to deadlines
- Prior experience working effectively in a matrix environment; experience mentoring/training others
- Data/Integration: XML/standards repositories, APIs, ALS, MDR (preferred); ETL/ELT experience; familiarity with AWS/Databricks
- Programming (preferred): One or more SQL, SAS, R or Python; R Shiny/Python app development
Benefits
- 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.
Company Overview
Company H1B Sponsorship