Associate Director, Electronic Data Capture Engineer Developer

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.

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director, Electronic Data Capture Developer 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.

POSITION OBJECTIVES:

As the Associate Director, Electronic Data Capture, you will:

• Lead a team of EDC Developers (Principal, Senior, and Associate) and oversee delivery of systems and documentation to support Takeda clinical trials. You will work with Takeda study teams and cross-functional partners to ensure consistent, compliant, and on-time execution of EDC build and maintenance activities across a portfolio of studies.
• 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.

POSITION ACCOUNTABILITIES:

• 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 elevate 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…