AD Clinical Trial Tools and Technologies, Non-standard Clinical Data Acquisition & Delivery
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 8, 2022
Job Description:
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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 DescriptionACCOUNTABILITIESAs the
Associate Director, Clinical Trial Tools and Technology, you will
create and implement standard processes governing end to end data
delivery integration activities for EDC, eCOA, PK, LAB, BIOMARKER
and IMAGING data. You will report to the Sr. Director, Clinical
Trial Tools and Technology.
- You will oversee creation of training associated with
integration activities for EDC, eCOA, PK, LAB, BIOMARKER and
IMAGING data.
- You will be responsible for identifying gaps and possible
improvements to all clinical data cleaning tools and processes to
ensure audit readiness and adherence to GCP guidelines. Ensure
systems are fit for purpose and ensure all validation activities
are thorough, documented and fit for purpose.
- Secure agreements with appropriate stakeholders (including but
not limited to Clinical Operations, Clinical Supplies, IT, and
Quality organizations) to develop technology strategies across
Clinical Studies in alignment with established Takeda SOPs &
Policies, and governance models.
- Manage team of employees and contractors in support of systems
and data integration
CORE ELEMENTS RELATED TO THIS ROLE
- Accountable for system delivery life cycle, including
deployment strategies, user training and management.
- Act as a primary business change agent to ensure adoption of
new capabilities and business process
- Serve as the first point of contact for Clinical Technology
vendors when collaboration is needed to ensure established
milestones and deliverables are met with the highest degree of
quality.
- Act as a process expert for operational and oversight
models.
- 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 Trial Tools & Technologies (CT3) group in a
formal inspection or audit.
- Set strategy for study level technology & deployment and
defines vendor oversight activities. .Leadership
- Manage small team of employees and contractors in support of
systems and data integration
- Demonstrated Business Relations Management experience with
multiple vendors, setting strategy and implementation for multiple
clinical technologies including but not limited to: electronic
Clinical Outcome Assessment (eCOA), electronic Patient Reported
Outcome (ePRO), Medical Devices, Interactive Voice/Web Response
System (IRT), Electronic Data Capture (EDC), and Clinical Data
Wearhouse.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS/BA required or MS preferred in a health-related, life
science area or technology-related fields.
- Minimum of 10 years' drug development experience
- Experience with clinical trial documents (protocols,
statistical analysis plans, CRFs, study reports) and processes
- Experience with FDA and ICH regulations and industry standards
and quality control principles.
- Project management skills and experience managing
implementation of eCOA, IRT, EDC, Clinical Data Wearhouse or CTMS
for large drug development programs
- Experience applying System Development Life Cycle (SDLC) and
developing strategies to address required changes to clinical trial
technologies due to evolving GXP regulations
- Business Relations Management experience with multiple vendors,
setting strategy and implementation for multiple clinical
technologies: electronic Clinical Outcome Assessment (eCOA),
electronic Patient Reported Outcome (ePRO), Interactive Voice/Web
Response System (IRT), Electronic Data Capture (EDC), Clinical Data
WearhouseBase Salary Range: $ 140,000 to $190,000, 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.This posting is made in compliance with
Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et
seq.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, Cherry Hill , AD Clinical Trial Tools and Technologies, Non-standard Clinical Data Acquisition & Delivery, Healthcare , Cherry Hill, New Jersey
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