Expertise and Functions - Provide support to either VP, CFT Director, Program/Project Manager or Engineering personnel in the areas of project scheduling, data gathering/analyses, database manipulation or population, preparation of technical/project reports or briefings, test plans and reports, and associated documentation, test, or Validation/Verification assistance. - Create realistic and accurate job descriptions. - Review resumes/conduct job interview process to fill positions as applicable. - Direct employee workload to ensure productivity and performance against job description. - Engage to manage positive employee relations and workplace atmosphere; work to resolve any personnel issues. - Conduct ongoing feedback – both informal and semiannual feedback, counseling if necessary. - Advise CFT Director as to which employees deserve recognition including but not limited to raises, promotions and awards. - Manage accuracy of employee timecards. - Ensure employees receive and perform any required training for position and company needs. - Manage/oversee/perform test or project events as assigned by leadership, report status and results. - Oversee/conduct test/trial, Validation/Verification and production work per Government requirements. - Attend conferences, meetings. - Conduct site-visits to CONUS/OCONUS locations prior to/during execution of contract. - Wellness checks on long duration contracts. - Designate/manage various teams at CONUS/OCONUS locations and perform in a Subject Matter Expert (SME) and/or technician role as required. - Work closely in producing production schedule - Set-up requirements for CFTs/coordinate travel, tools/equipment and base access. - Following engineering guidance, technical orders, and drawings. Make recommendations for improvements to enhance concept, quality, manufacturability, and maintainability. - Manage, perform, and oversee moderately complex assembly/test functions utilizing mechanical skills, hand and power tools, test equipment, and inspection measurement equipment. - Create, document, and maintain records identifying compliance with assigned tasks and requirements. - Develop, update, maintain work instructions, work control documents, and Ground Operations Procedures (GOPs) as applicable. - Research/document materials/CFT requirements for bid proposals. - Build long-term relationships with new and existing customers, suppliers, and vendors. - Develop team members into valuable multi-faceted, multi-skilled individuals. - Maintain accountability and serviceability of all KIHOMAC materials, tools, and test equipment within area of responsibility. - Ensure proper tools/tool kits and equipment are sourced and used per customer/MFG requirements. - Attend meetings, report/brief status updates and results as required. - Provide leadership and management direction to assigned employees to ensure quality performance in support of Government programs. - Communicate with VP, CFT Director, Program/Project Manager to ensure contractual needs and concerns are addressed. - Guide employees to ensure compliance with labor laws and company policies/processes. - Serve as link between upper management and employees; disseminate company information as appropriate – goals/changes/updates/news. - Coordinate with CFT Director and/or VP on corporate matters. - Maintain high ethical/professional standards of performance, demeanor, and judgment always. - Observe all safety rules and maintain a clean and foreign object damage (FOD) free work area. - Other duties as assigned

Expertise and Functions - Provide support to either VP, CFT Director, Program/Project Manager or Engineering personnel in the areas of project scheduling, data gathering/analyses, database manipulation or population, preparation of technical/project reports or briefings, test plans and reports, and associated documentation, test, or Validation/Verification assistance. - Create realistic and accurate job descriptions. - Review resumes/conduct job interview process to fill positions as applicable. - Direct employee workload to ensure productivity and performance against job description. - Engage to manage positive employee relations and workplace atmosphere; work to resolve any personnel issues. - Conduct ongoing feedback – both informal and semiannual feedback, counseling if necessary. - Advise CFT Director as to which employees deserve recognition including but not limited to raises, promotions and awards. - Manage accuracy of employee timecards. - Ensure employees receive and perform any required training for position and company needs. - Manage/oversee/perform test or project events as assigned by leadership, report status and results. - Oversee/conduct test/trial, Validation/Verification and production work per Government requirements. - Attend conferences, meetings. - Conduct site-visits to CONUS/OCONUS locations prior to/during execution of contract. - Wellness checks on long duration contracts. - Designate/manage various teams at CONUS/OCONUS locations and perform in a Subject Matter Expert (SME) and/or technician role as required. - Work closely in producing production schedule - Set-up requirements for CFTs/coordinate travel, tools/equipment and base access. - Following engineering guidance, technical orders, and drawings. Make recommendations for improvements to enhance concept, quality, manufacturability, and maintainability. - Manage, perform, and oversee moderately complex assembly/test functions utilizing mechanical skills, hand and power tools, test equipment, and inspection measurement equipment. - Create, document, and maintain records identifying compliance with assigned tasks and requirements. - Develop, update, maintain work instructions, work control documents, and Ground Operations Procedures (GOPs) as applicable. - Research/document materials/CFT requirements for bid proposals. - Build long-term relationships with new and existing customers, suppliers, and vendors. - Develop team members into valuable multi-faceted, multi-skilled individuals. - Maintain accountability and serviceability of all KIHOMAC materials, tools, and test equipment within area of responsibility. - Ensure proper tools/tool kits and equipment are sourced and used per customer/MFG requirements. - Attend meetings, report/brief status updates and results as required. - Provide leadership and management direction to assigned employees to ensure quality performance in support of Government programs. - Communicate with VP, CFT Director, Program/Project Manager to ensure contractual needs and concerns are addressed. - Guide employees to ensure compliance with labor laws and company policies/processes. - Serve as link between upper management and employees; disseminate company information as appropriate – goals/changes/updates/news. - Coordinate with CFT Director and/or VP on corporate matters. - Maintain high ethical/professional standards of performance, demeanor, and judgment always. - Observe all safety rules and maintain a clean and foreign object damage (FOD) free work area. - Other duties as assigned

Title: Senior Manager, Clinical Data Ingestion Location: USA - MA - Virtual Job Description: By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description 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 Ingestion 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 Ingestion is responsible for ingesting, validating, and operationalizing clinical data feeds into clinical data review platforms (e.g., Veeva CDB, Elluminate, JReview) to enable efficient, high-quality clinical data review. This role focuses on strong ingestion principles, building and scaling reusable ingestion frameworks, and establishing monitoring and controls for vendor transfers and enterprise sources (e.g., EDC, CTMS) as well as managing downstream exports to enable analytics and programming teams. ACCOUNTABILITIES: - Ingest clinical data from EDC/CTMS and vendors (e.g., labs, eCOA, imaging, safety) into Veeva CDB/Elluminate/JReview per specifications and refresh cadence. - Execute and support file/API loads, including mapping, transformations, referential integrity, and controlled reprocessing. - Apply ingestion best practices: standardization, automated QC/validation, reconciliation, auditability/lineage, and incremental loads. - Build and maintain a reusable ingestion framework and standards (templates, metadata-driven mappings, reusable QC rules, runbooks) to accelerate onboarding and improve consistency. - Operate transfer monitoring and ingestion operations: expected vs received, timeliness/completeness checks, alerting/escalation, scheduling/re-runs, defect triage, and KPI/SLA tracking. - Ensure datasets are review-ready and manage downstream exports to internal consumers with clear data contracts and refresh expectations. - Partner with vendors and stakeholders to define/maintain transfer specs and acceptance criteria; provide SME troubleshooting and document fixes for repeatable operations. - Follow controlled documentation and change practices for regulated clinical processes, maintaining validation/traceability evidence and audit-ready records as required. EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: Education: - BS/BA (or equivalent) plus 7+ years in data ingestion/integration. ETL/ELT operations, or clinical data pipeline support, ideally supporting clinical data review and recurring study/vendor transfers. Technical Competencies - Preferred platform exposure: Experience ingesting data into Veeva CDB, Elluminate, and/or JReview (or comparable clinical data review systems). - Clinical data ingestion principles: Strong understanding of end-to-end ingestion concepts including data contracts/specifications, refresh cadence, incremental vs full loads, controlled reprocessing, reconciliation, and traceable lineage. - Data quality & review readiness: Ability to design/execute automated QC/validation checks, completeness/timeliness verification, and reconciliation routines to ensure datasets are review-ready. - Data formats & interfaces: Hands-on experience with CSV, JSON, XML and file-based and/or API-based integrations; familiarity with secure transfer patterns (e.g., SFTP/managed file transfer concepts). - Querying & scripting: Strong SQL skills; working proficiency in Python (preferred) or similar scripting to automate ingestion, QC, parsing, and operational tasks. - Frameworks & reusability: Demonstrated ability to build or extend reusable ingestion components (metadata-driven mappings, templates, reusable QC rules, standard runbooks). - Monitoring & operations: Experience building/using monitoring for transfers and pipelines (e.g., expected vs received, timeliness/completeness checks, alerting, incident triage, reruns, KPI/SLA reporting). Domain / Business Competencies - Source system familiarity: Working knowledge of common clinical sources such as EDC, CTMS, and vendor domains (e.g., labs, eCOA/ePRO, imaging, safety) and how those feeds typically arrive and change over time. - Downstream enablement: Understanding of downstream consumption needs (data review workflows, exports to CDM/analytics/programming) and ability to support stable, well-documented exports. Compliance & Documentation - Controlled processes mindset: Strong documentation discipline (specs, mappings, runbooks, issue logs) and comfort operating in controlled/regulated environments. - Preferred: Exposure to GxP/CSV expectations, change control, and maintaining audit-ready operational evidence (as applicable to the organization/process). Working Style: - Strong cross-functional communication and stakeholder management (vendors, CDM, data review, IT, analytics/programming. - Detail-oriented, highly organized, Strong collaboration and communication; organized, self-directed, proactive problem-solver and able to manage recurring operational workloads while driving issues to closure and preventing recurrence This position is currently classified as “ remote” in accordance with Takeda’s Hybrid and Remote Work policy. Empowering Our People to Shine Discover more at takedajobs.com No Phone Calls or Recruiters Please. #LI-JV2 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: USA - MA - Virtual U.S. Base Salary Range: $137,000.00 - $215,270.00 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. Locations USA - MA - Virtual Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

• Continuously review quality control processes, procedures, and capabilities in order to sustain the most cost effective and efficient methods for meeting quality requirements. • Make recommendations for improvement as appropriate. • Review client QC requirements and ensure that quality control documentation for the project meets contractual requirements. • Review and approve Contractor and subcontractor quality control documentation to ensure their planned activities meet contractual requirements. • Understand client needs and requirements to develop effective quality control processes. • Keep accurate documentation and perform statistical analysis. • Submit detailed reports to appropriate executives. • Be on the lookout for opportunities for improvement and develop new efficient procedures requirements.