Senior Electronic Data Capture Engineer - Trenton, United States - Takeda Pharmaceutical

Description

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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 Senior Electronic Data Capture (EDC) Engineer.

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.

Objectives:

As the Senior EDC Engineer you will work on EDC activities and will oversee delivery of systems and documentation to support of Clinical studies. You will work with Takeda study team to develop eCRF specifications, build and/or oversee implementation of Case Report Forms (eCRFs) for clinical trials. Manage and oversee EDC system configuration, EDC Build, and integrations with EDC. Create and own database build SOPs and processes. 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. 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.

Key Accountabilities

• Create eCRF specifications, design, develop and validate clinical trial setup in EDC
• Review edit check specifications and program edit checks at the trial level
• Setup different instances of study URL (eg: UAT, production, testing etc.,)
• Setup and configure user accounts for study teams
• Setup and manage blinded and unblinded study configurations
• Serve as SME for all database related activities
• Configure other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc.,
• Knowledge of creating custom functions within EDC systems
• Work closely with EDC vendors on system enhancements and bug fixes
• Ability to troubleshoot database setup as per study needs
• Prepare, test and implement post production changes as per study needs while ensuring data integrity
• Archive and retire the study URL after database lock
• Partner with appropriate team members to establish technology standards and governance models
• Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
• Establish and support business process SOPs and Work Instructions
• Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizations
• Be a primary change agent to ensure adoption of new capabilities and business process
• Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality.
• Work with leaders to resolve issues affecting the delivery of clinical trials
• Collaborate with standards team in creating standard CRF libraries for study level consumption
• Work closely with data engineers and data management programmers at study level integration and delivery
• Lead technology vendor oversight activities.
• Be a process expert for operational and oversight models.
• Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks.
• Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents
• Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit.
• Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables.
• Adaptable to new ways of working using technology to accelerate clinical trial setup

Education and Experience Requirements:

• Bachelor's degree or related experience.
• Knowledge of drug development process.
• Minimum of 10+ years' experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields.
• Hands-on experience with at least one EDC system (e.g.: Medidata Rave, Inform, Veeva etc.,)
• Understanding of programming in CQL, working with JSON format and/or C# is preferred
• Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system
• Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint)

This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.

Takeda is proud in its commitment of creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location:

U.S. Base Salary Range:

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and/or long-termincentives. 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. 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.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

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