Principal, Electronic Data Capture Developer

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Principal, 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 Principal EDC Developer you will:

• 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. 
• 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. 
• Will be experienced in Veeva Clinical Data continue developing new skills associated with EDC technologies and the Veeva Platform. 
• Oversee and supervise our global Functional Service Providers (FSPs).

POSITION ACCOUNTABILITIES:

• 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
• 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.,
• Work closely with EDC vendors to understand system enhancements and limitations
• 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
• Monitor general progress to ensure clinical programming milestones and deliverables are met with quality for all concurrent projects
• 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
• Support adoption of new capabilities and business process
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