Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Electronic Data Capture (EDC) Engineer (Lead/Assoc. Manager) – Alta Petens.
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 EDC Engineer you will work on EDC activities and oversee delivery of systems and documentation to support Takeda Clinical trials. You will work with Takeda study teams to develop eCRF specifications, build and/or oversee implementation of Case Report Forms (eCRFs) for clinical trials. The EDC Engineer will manage and oversee EDC system configuration, dictionaries, and user administration. The EDC Engineer operates in compliance with Takeda SOPs and processes while working with Data Management and Standards Teams to enhance existing processes. The EDC Engineer will understand Clinical Data Acquisition Standards Harmonization (CDASH) and Study Data Tabulation Model (SDTM) standards and concepts while considering EDC platform best practices. The EDC Engineer will continue developing new skills associated with EDC technologies.
Create eCRF specifications, design, program, and validate clinical trial setup
Create edit check specifications and program edit checks at the trial level
Review and execute UAT scripts testing the setup of the clinical study
Setup different instances of trial URL (eg: UAT, production, testing etc.,)
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
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 data engineers 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 and Experience Requirements:
Bachelor's degree or related experience.
Knowledge of drug development process.
Minimum of 3+ 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, IBM Clinical, Veeva etc.,)
Understanding of CQL/SQL, Python, and/or C# is preferred
Experience integrating 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, R or Python, Data Warehouses, SharePoint)
This position is currently classified as “remote” in accordance with Takeda’s Hybrid and Remote Work policy.
Base Salary Range: $87,500.00 to $125,000.00, based on candidate professional experience level.Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.
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
Boston, MAWorker Type