Principal, Electronic Data Capture Developer

About This Role

This role involves working on Electronic Data Capture (EDC) activities, overseeing the delivery of systems and documentation for Takeda Clinical trials. The Principal EDC Developer will collaborate with study teams to develop eCRF specifications, build, and oversee implementation of Case Report Forms (eCRFs) for clinical trials.

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.
• Provide mentorship and guidance to study leads, proactively manage risks, and lead escalation and resolution of complex issues.
• Operate in compliance with Takeda SOPs and processes while enhancing existing processes with Data Management and Standards Teams.
• 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 (e.g., UAT, production, testing etc.).
• Lead and drive the database build by owning and managing the E2E timeline for build.

Requirements

• Bachelor's degree or related experience
• Knowledge of drug development process
• 12+ years’ experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields
• 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
• 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

Qualifications

• Bachelor's degree or related experience
• 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.

Nice to Have

• Understanding of CQL and/or C#

Skills

* Required skills

Benefits