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
• Collaborate with standards team in creating standard EDC libraries for study level consumption
• Assist data management with CRO oversight of EDC Builds
• Provide SME expertise to study teams having site entry and/or bug issues in Production
• Work closely with Electronic Data Capture Developers and Data Managers on study level integrations and deliveries
• Assist in technology vendor oversight activities.
• 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 job function for submission readiness
• Track study deliverables and escalate any risk(s) for major data management deliverables
• Adaptable to new ways of working using technology to accelerate clinical trial setup

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

• Bachelor's degree or related experience.
• Knowledge of drug development process.
• 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 in systems such as Veeva CDMS, RAVE, Inform, Zelta, Medrio, etc..
• Hands-on experience with designing in Veeva Clinical Data (formerly Veeva CDMS) (Minimum 4+ years' experience designing in Veeva)
• Understanding of CQL and/or C# is preferred but not required
• Experience overseeing integrations of the EDC database with other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,)
• Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, IRT, eCOA, SAS, SharePoint)

This position is currently classified as " remote" in accordance with Takeda's Hybrid and Remote Work policy.
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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:
USA - MA - Virtual
U.S. Base Salary Range:
$137,000.00 - $215,270.00
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-term incentives. 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.
Locations
USA - MA - Virtual
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job Exempt
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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