Associate Director, Electronic Data Capture Engineer Developer

Takeda

7d•Remote

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 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.

Requirements

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)
Understanding of CQL and/or C# is preferred but not required
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

Nice To Haves

Understanding of CQL and/or C# is preferred but not required

Responsibilities

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

Benefits

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.

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