Senior Manager, Clinical Data Configuration

Takeda

5d • Hybrid

About The Position

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Manager, Clinical Data Configuration in our Cambridge, MA office. 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 realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. OBJECTIVES: The Senior Manager, Clinical Data Configuration Representative sits within R&D’s Testing, Innovation, and Data Enablement organization and is responsible for configuring study-level clinical data extractions visualizations and transformations across multiple data sources in alignment with Data Transfer Agreements and technical specifications. This role partners with internal and external stakeholders and data engineers to define requirements, resolve issues, and deliver high-quality, compliant data to timelines, while contributing to standards/SOPs, leading process improvements, and mentoring team members to ensure consistent, inspection-ready delivery.

Requirements

• 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)
• Strong clinical trial terminology and data transfer specification knowledge; understanding of SDTM.
• Visualization/configuration: experience designing visual objects and libraries; programming clinical trial visualization tools
• Tools/Ways of Working: Microsoft Office
• Strong 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.

Nice To Haves

• Data/Integration: XML/standards repositories, APIs, MDR (preferred); ETL/ELT experience; familiarity with AWS/Databricks.
• Programming (preferred): One or more SQL, SAS, R or Python; R Shiny/Python app development.

Responsibilities

• Configure study-level data extraction and transformations across multiple data sources per Data Transfer Agreement and technical specifications.
• Partner with internal/external stakeholders and data engineers to define requirements, resolve issues, and deliver to timelines in a matrix environment.
• Ensure high-quality, compliant data delivery (correct formats/frequency), with readiness to support and defend work in audits/inspections (FDA expectations).
• Contribute to standards, SOPs, and best practices by providing input, supporting development/maintenance, and participating in related training.
• Lead process improvement/workstreams to improve efficiency and consistency of transfer-spec and configuration execution.
• Mentor and train team members; provide guidance and knowledge-sharing across the team.
• Perform quality oversight including review of vendor-performed activities as needed.
• May mentor/manage Functional Service Providers (FSP)

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level