Electronic Data Capture (EDC) Engineer (Manager/Sr. Manager) - Alta Petens

Company: Takeda Pharmaceutical
Location: Brooklyn
Posted on: January 27, 2023

Job 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 Electronic Data Capture (EDC) Engineer (Manager/Sr. Manager) - Alta Petens 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.

Objectives:

As the 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 or oversee implementation of Case Report Forms (eCRFs) for clinical trials. Manage and oversee EDC system configuration and dictionaries. Create and own database build SOPs and processes. You will provide consulting services to ensure implementation of technology.

You will work with Data Management and standards teams to implement new processes. You will enhance existing processes for efficient and compliant way of Clinical trial build. The EDC Engineer maintains and serves as an expert for implementation of EDC best practices.

The EDC Engineer would 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 process
• Create edit check specifications and setup edit checks at trial level
• Create and implement UAT scripts to test the setup of the clinical study
• 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
• Be the SME for all database related activities
• Setup, configure, validate and integrate 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 regarding any tool related issues in the system
• Ability to troubleshoot database setup as per study needs
• Prepare, test and implement post production changes as per study needs
• Archive and retire the study URL after database lock
• Partner with appropriate team members to establish technology standards and governance models
• Establish and support business process SOPs.
• 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 5+ years' experience (Manager), minimum of 7+ years' experience (Sr. Manager) 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.,)
  • Experience 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 "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.
    
    Base Salary Range: $102,200.00 to $146,000.00, 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.
    
    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.
    
    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
    
    Boston, MA
    
    Worker Type
    
    Employee
    Worker Sub-Type
    
    Regular
    Time Type
    
    Full time

Keywords: Takeda Pharmaceutical, New York , Electronic Data Capture (EDC) Engineer (Manager/Sr. Manager) - Alta Petens, Engineering , Brooklyn, New York