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Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents. Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system.
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The EDC Engineer will work with Data Management and Standards teams to implement new processes as well as enhance existing processes for efficiencies and compliance with Takeda Clinical trial builds.
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Create eCRF specifications, design, develop and validate clinical trial setup in EDC. Review edit check specifications and program edit checks at the trial level. Adaptable to new ways of working using technology to accelerate clinical trial setup.
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Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,) Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint.
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Configure other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc., Prepare, test and implement post production changes as per study needs while ensuring data integrity.
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U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.
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Manage and oversee EDC system configuration, EDC Build, and integrations with EDC. Create and own database build SOPs and processes. As the Senior EDC Engineer you will work on EDC activities and will oversee delivery of systems and documentation to support of Clinical studies.
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The EDC Engineer maintains and serves as an expert for implementation of EDC best practices and is expected be familiar with leading EDC technologies available on the market. You will continue developing new skills associated with EDC technologies.
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Join us as a Senior Electronic Data Capture (EDC) Engineer. Work closely with EDC vendors on system enhancements and bug fixes. Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit.
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Knowledge of creating custom functions within EDC systems. Setup different instances of study URL (eg: UAT, production, testing etc.,) Minimum of 10+ years’ experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields.
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The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine.
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You will work with Takeda study team to develop eCRF specifications, build and/or oversee implementation of Case Report Forms (eCRFs) for clinical trials. Knowledge of drug development process. Work with leaders to resolve issues affecting the delivery of clinical trials.
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Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables. 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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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. Work closely with data engineers and data management programmers at study level integration and delivery.
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Archive and retire the study URL after database lock. Be a primary change agent to ensure adoption of new capabilities and business process. We understand compensation is an important factor as you consider the next step in your career.
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