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Senior Electronic Data Capture Engineer

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  • Job Level: Senior
  • Travel: Minimal (if any)

Within Takeda’s Data Sciences Institute, we harness the insight of data and digital to speed the development of new medicines to patients. The Data Sciences Institute (DSI) is primarily focused on getting medicines to patients faster through innovation and efficiencies driven by data and analytics.

We nurture a culture that encourages disciplined risk-taking, supports innovation, values diversity and emphasizes implementation.

We want to hire and develop the best talent to join us on our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine!

Job ID R0119677 Date posted 03/22/2024 Location Remote

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’sPrivacy Noticeand Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.

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.


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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No Phone Calls or Recruiters Please.

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:

Massachusetts - Virtual

U.S. Base Salary Range:

$108,500.00 - $170,500.00

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. 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. 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.

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.


Massachusetts - Virtual

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Full time


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Where you fit in

When you join our Data Sciences Institute team, you’ll connect with a diverse and talented group of scientists, engineers and analysts. Together, you’ll define cutting-edge algorithms, conduct pharmacology-based modeling and explore new approaches to data services. In a collaborative environment marked by strong, open and honest leadership, you’ll take charge of your professional advancement as you work on important projects that grow your skills and lead to ongoing opportunities.

A career within the Data Sciences Institute at Takeda will give you everything you need to succeed professionally. You’ll see up close that what you do with information and insight has the power to impact the lives of patients — today and for generations to come. Working here, you’ll understand that our people-first perspective extends beyond patients to include our Takeda team, our families and the communities where we all work and live.

  • Work with various data sources

  • Apply a breadth of methodologies

  • Develop analysis pipelines

  • Design studies

We’re using the newest technology and methods, like wearable devices and machine learning, to better understand the health of patients participating in our trials.
headshot of ariel dowing

Ariel Dowling - Head, Sensing & Measurement, Digital Health Sciences

The energy, professionalism and commitment that I experienced in every encounter, starting from the interview process, to meeting with the hiring manager, through to receiving an offer, left me feeling a certain level of consistency and thoughtfulness. That made me really feel enthusiastic.
headshot of brian johnson

Brian Johnson - Head, R&D Technology, Data Sciences Institute

Being able to predictably deliver on our portfolio priorities is where we have laser-focus each and every day. By doing this, we keep our eye on the prize of bringing new medicines to patients, and show the value that these treatments can bring to their lives.
headshot of simon davies

Simon Davies - Head, Statistical & Quantitative Sciences, Data Sciences Institute

How you'll shine

Many talents one goal

Our pipeline

Our internal research capabilities and external partnerships contribute to an R&D engine that has produced exciting new molecular entities (NMEs) across our core Therapeutic Areas. Check out our pipeline and see how we’ll continue delivering a steady stream of next-generation therapies.

Learn more

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

We're Steadfast In Our Commitment to Four Key Imperatives


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.


Create an exceptional people experience.


Protect our planet.

Data & Digital

Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

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