Electronic Data Capture (EDC) Build Specialist
Company: Takeda Pharmaceutical
Location: Jersey City
Posted on: May 13, 2022
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 and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionAs the Electronic Data Capture (EDC) Build
Specialist you will oversee delivery of systems and documentation
to support of Clinical studies. You will work with Takeda study
team to build or oversee implementation of eCase Report Forms
(eCRFs) for clinical trials. 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 Build Specialist maintains and serves
as an expert for implementation of EDC best practices.The EDC Build
Specialist would be familiar with leading EDC technologies
available on the market. You will continue developing new skills
associated with EDC technologies.Key Accountabilities
- 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
- 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.Education and
Experience Requirements:
- Bachelor's degree or related experience.
- Knowledge of drug development process.
- 7+ years experience in Data Management, Programming, Clinical
IT, or other Clinical Research related fields.
- Understanding of industry standard technologies to support
Clinical Development needs (e.g. CTMS, SAS, Data Warehouses,
Sharepoint)This job posting excludes CO applicants.Location:
Cambridge - VirtualBase Salary Range: $120,500-140,000 based on
candidate professional experience level. Employee may also be
eligible for Short Term and Long Term incentive benefits. Employees
are eligible to participate in Medical, Dental. Vision, Life
Insurance, 401(k), Charitable Contribution Match, Company Holidays,
Personal & Vacation Days, Student Loan Repayment Program and Paid
Volunteer Time Off. If candidate is not eligible for any benefits
or other comp., those can be excludedThis posting is made in
compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. -
8-5-101 et seqTakeda 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.Absent an approved religious or medical reason, all US
office-based and lab-based Takeda employees who work fully on-site
or in a hybrid model (as determined by Takeda) must be fully
vaccinated to work at a Takeda site or to engage with Takeda
colleagues or anyone else on behalf of Takeda. US field-based
employees must be fully vaccinated as a condition of employment,
absent an approved religious or medical reason. US employees who
work at a Takeda manufacturing facility, and those who work at a
BioLife center or BioLife lab, may be subject to different
guidelines. If you are contacted by a Takeda recruiter about your
job application, we encourage you to seek more information on the
applicable guidelines for the Business Unit/Function to which you
have applied.EEO StatementTakeda 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.LocationsMassachusetts -
VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull
time
Keywords: Takeda Pharmaceutical, Jersey City , Electronic Data Capture (EDC) Build Specialist, Other , Jersey City, New Jersey
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