Takeda · 13 hours ago
Associate Director, Electronic Data Capture Engineer Developer
United States
Full-time
Hybrid
Senior Level, Lead/Staff, Director/Executive
$154K/yr - $241K/yr
15+ years expTakeda is a patient-focused, innovation-driven company transforming the pharmaceutical industry through R&D-driven market leadership. The Associate Director, Electronic Data Capture Developer will lead a team of EDC Developers, ensuring the delivery of systems and documentation to support clinical trials while maintaining compliance and quality across multiple studies.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Lead a team of EDC Developers (Principal, Senior, and Associate) and oversee delivery of systems and documentation to support Takeda clinical trials
Be accountable for staffing and coverage planning across the EDC portfolio, coaching/mentorship and performance management for direct reports, and ensuring consistent application of EDC standards, processes, and best practices
Operate in compliance with Takeda SOPs and processes while partnering with Data Management, Standards, and other cross-functional teams to enhance existing processes
Understand Clinical Data Acquisition Standards Harmonization (CDASH) and Study Data Tabulation Model (SDTM) standards and concepts while considering EDC platform best practices
Lead, coach, and mentor a team of direct reports (Principal, Senior, and Electronic Data Capture Developers) to ensure consistent execution and development across levels
Own staffing, capacity, and coverage planning across the EDC portfolio (assignments, back-up coverage, onboarding)
Own performance management activities (goal setting, feedback, development planning) for direct reports
Accountable for overall quality, compliance, and on-time delivery of EDC studies and deliverables across the assigned portfolio
Ensure consistent application of EDC standards, processes, and best practices across all studies under oversight
Establish and drive team operating mechanisms to track milestones, manage intake/prioritization, and proactively identify and escalate risks
Lead decision-making for EDC design, build strategy, validation approach, and risk mitigation across assigned studies
Oversee and ensure end-to-end database build timelines are defined, managed, and met
Perform and/or oversee and document functional testing of all EDC design components
Lead and oversee EDC build delivery by providing strategic direction and governance for eCRF specification, design, programming, validation, and overall trial setup
Provide trial-level oversight of data quality controls by reviewing/approving edit check strategy and specifications, ensuring appropriate implementation and traceability, and holding the team accountable for performance and defect resolution
Own environment and release governance across trial URL instances (e.g., UAT, production, test), ensuring controlled access, appropriate segregation, readiness criteria, and compliant promotion of builds between environments
Establish and manage testing strategy and execution oversight for functional testing of all EDC design components, including resourcing, documentation expectations, issue triage, and sign-off readiness
Oversee integration and configuration delivery (e.g., local labs, targeted SDV, integrations), ensuring functional alignment, validation approach, risk management, and end-to-end reliability
Govern post-production change control by assessing impact, approving priorities, coordinating implementation plans, ensuring data integrity and auditability, and driving timely, compliant delivery of study changes
Provide oversight for troubleshooting database design and maintenance issues and resolving complex production issues
Ensure archiving and retirement of the study URL after database lock
Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents
Participate in submission readiness for assigned scope and support internal/vendor audits and health authority inspections as applicable
Partner with appropriate team members to establish technology standards and best practices
Collaborate with standards team in creating standard EDC libraries for study level consumption
Assist Data Management with CRO oversight of EDC builds
Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizations
Serve as the front-facing audit and inspection lead for EDC build/configuration and related computerized system validation activities; coordinate preparation, participation, and responses for sponsor/CRO/vendor audits and health authority inspections as applicable
Own audit readiness for the EDC delivery scope by ensuring inspection-ready documentation (e.g., validation packages, test evidence, change control, access controls, issue logs), consistent traceability, and adherence to SOPs, GxP, and data integrity expectations
Oversee team audit/inspection preparation activities including readiness assessments, internal reviews, CAPA ownership/support, risk identification/mitigation, and periodic training/coaching to close compliance gaps
Drive cross-functional alignment during audits/inspections by coordinating SMEs, ensuring consistent messaging, managing evidence requests to closure, and communicating status, risks, and outcomes to study/program and quality leadership
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Track study deliverables and escalate any risk(s) for major data management deliverables
Adaptable to new ways of working using technology to accelerate clinical trial setup
Performs other duties as assigned
Qualification
Required
Bachelor's degree or related experience
Knowledge of drug development process
Minimum of 15+ years' experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields
Minimum 12+ years' experience in programming clinical trials in EDC in systems such as Veeva CDMS, RAVE, Inform, Zelta, Medrio, etc
Hands-on experience with designing in Veeva Clinical Data (formerly Veeva CDMS)
Experience overseeing integrations of the EDC database with other clinical trial modules (e.g. lab, safety, IRT, coding etc.)
Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, IRT, eCOA, SAS, SharePoint)
Demonstrated experience providing portfolio oversight of multiple EDC studies and study leads simultaneously (delivery, quality, compliance, and timelines)
Proven ability to mentor, coach, and develop and mentor senior level EDC leads
Experience leading cross-functional decision-making, risk management, and escalation for complex clinical trials
Experience supporting internal audits, vendor audits, and health authority inspections related to EDC systems and data
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Adaptable to new ways of working using technology to accelerate clinical trial setup
Preferred
Understanding of CQL and/or C#
Benefits
Short-term and/ or long-term incentives
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
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
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