Takeda · 11 hours ago
Principal, Electronic Data Capture Developer
United States
Full-time
Hybrid
Senior Level, Lead/Staff
$137K/yr - $215K/yr
12+ years expTakeda is a patient-focused, innovation-driven pharmaceutical company seeking a Principal, Electronic Data Capture Developer. This role involves overseeing EDC activities, managing system configurations, and ensuring the quality and compliance of EDC studies to support clinical trials.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Work on EDC activities and oversee delivery of systems and documentation to support Takeda Clinical trials
Work with Takeda study teams to develop eCRF specifications, build and/or oversee implementation of Case Report Forms (eCRFs) for clinical trials
Manage and oversee EDC system configuration, dictionaries, and integrations
Accountable for the successful delivery, quality, and compliance of all EDC studies and study leads under their oversight. They provide mentorship and guidance to study leads, proactively manage risks, and lead escalation and resolution of complex issues to ensure study milestones are met
Operates in compliance with Takeda SOPs and processes while working with Data Management and Standards 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
Create eCRF specifications, design, program, and validate clinical trial setup of EDC Databases
Review edit check specifications and program edit checks at the trial level
Setup different instances of trial URL (eg UAT, production, testing etc.,)
Ability to lead and drive the database build by owning and managing the E2E timeline for build
Accountable for overall quality, compliance, and on-time delivery of all EDC studies and study leads within assigned portfolio
Ensure consistent application of EDC standards, processes, and best practices across all studies under oversight
Provide mentorship, coaching, and technical guidance to EDC Study Leads to support skill development and consistent execution
Lead decision-making for EDC design, build strategy, and risk mitigation across assigned studies
Represent EDC in cross-functional governance forums and escalate risks and decisions as appropriate
Drive continuous improvement initiatives for EDC build, review, and delivery processes in collaboration with Data Management and Standards teams
Configure and maintain user accounts for study teams and site users
Setup and manage blinded and unblinded study configurations
Perform and document functional testing of all EDC design components
Setup, configure, and validate integration modules within the EDC ecosystem such as coding, IRT, eCOA, safety system, local labs etc
Ability to identify and troubleshoot database design and maintenance issues
Prepare, test, and implement post-production changes as per study needs while ensuring data integrity
Archive and retire the study URL after database lock
Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
Partner with appropriate team members to establish technology standards and best practices
Adhere to and support business process SOPs
Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizations
Collaborate with standards team in creating standard EDC libraries for study level consumption
Assist data management with CRO oversight of EDC Builds
Provide SME expertise to study teams having site entry and/or bug issues in Production
Work closely with Electronic Data Capture Developers and Data Managers on study level integrations and deliveries
Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents
Participate in preparing job function for submission readiness
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 12+ years' experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields
Minimum 10+ 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 technical and functional oversight of multiple EDC studies and study leads simultaneously
Proven ability to mentor, coach, and develop EDC study 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
Preferred
Understanding of CQL and/or C# is preferred but not required
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
2026-01-25
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2026-01-23
2026-01-22
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