Principal, Electronic Data Capture Developer

Role Summary

Principal, Electronic Data Capture (EDC) Developer based in Cambridge, MA. You will lead EDC activities, oversee delivery of systems and documentation to support Takeda clinical trials, and collaborate with study teams to develop eCRF specifications and implement eCRFs. You will ensure quality and compliance across EDC programs and mentor study leads to meet milestones.

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.

Qualifications

• Required: Knowledge of drug development process.
• Required: Minimum of 12+ years’ experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields.
• Required: Minimum 10+ years’ experience in programming clinical trials in EDC in systems such as Veeva CDMS, RAVE, Inform, Zelta, Medrio, etc.
• Required: Hands-on experience with designing in Veeva Clinical Data (formerly Veeva CDMS).
• Preferred: Understanding of CQL and/or C# is preferred but not required.
• Required: Experience overseeing integrations of the EDC database with other clinical trial modules (e.g. lab, safety, IRT, coding etc.).
• Required: Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, IRT, eCOA, SAS, SharePoint).
• Required: Demonstrated experience providing technical and functional oversight of multiple EDC studies and study leads simultaneously.
• Required: Proven ability to mentor, coach, and develop EDC study leads.
• Required: Experience leading cross-functional decision-making, risk management, and escalation for complex clinical trials.
• Required: Experience supporting internal audits, vendor audits, and health authority inspections related to EDC systems and data.

Education

• Bachelor's degree or related experience.