Electronic Data Capture (EDC) Engineer (Manager/Sr. Manager) - Alta Petens - REMOTE
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: January 23, 2023
Job Description:
By clicking the "Apply" button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda's Privacy Notice and Terms of Use . I further attest
that all information I submit in my employment application is true
to the best of my knowledge. 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!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 setupEducation 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
"remote" 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, Cherry Hill , Electronic Data Capture (EDC) Engineer (Manager/Sr. Manager) - Alta Petens - REMOTE, Engineering , Cherry Hill, New Jersey
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