Senior Electronic Data Capture Engineer
Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: April 17, 2024
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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 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.
Objectives:
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.
Discover more at takedajobs.com
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 - VirtualU.S. Base Salary Range:
$108,500.00 - $170,500.00The 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.
Locations
Massachusetts - VirtualWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full time #LI-Remote
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Keywords: Takeda Pharmaceutical, West Hartford , Senior Electronic Data Capture Engineer, Engineering , Jersey City, Connecticut
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