at Takeda Pharmaceuticals in Montpelier, Vermont, United States
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 (Senior/Principal) – Alta Petens based remotely.
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 integrations. 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
+ Review edit check specifications and program edit checks at the trial level
+ 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
+ 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 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 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, IBM Clinical, Veeva etc.). Veeva is preferred
+ 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: $105,000 to $150,000 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.?
The final salary offered for this position may take into account a number of factors including, but not limited to, location, skills, education, and experience.
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