Electronic Data Capture (EDC) Engineer (Manager/Sr. Manager) - Alta Petens
Company: Takeda Pharmaceutical
Posted on: January 28, 2023
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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 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
- Create eCRF specifications, design, develop and validate
clinical trial setup process
- Create edit check specifications and setup edit checks at trial
- Create and implement UAT scripts to test the setup of the
- Setup different instances of study URL (eg: UAT, production,
- Setup and configure user accounts for study teams
- Setup and manage blinded and unblinded study
- 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
- 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
- Work with leaders to resolve issues affecting the delivery of
- 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
"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, Newark , Electronic Data Capture (EDC) Engineer (Manager/Sr. Manager) - Alta Petens, Executive , Newark, New Jersey
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