Manager, Third Party Data Integration (REMOTE)
Company: Takeda Pharmaceutical
Posted on: November 25, 2022
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information I provide in my application will be processed in line
that all information I submit in my employment application is true
to the best of my knowledge.Job DescriptionOBJECTIVES/PURPOSE As
part of the Clinical Trials Tools & Technologies organization, this
role is accountable for the following activities:
- Manage standard processes governing end-to-end data delivery
integration activities for EDC, eCOA, PK, LAB, BIOMARKER, and
- Create Data Transfer Agreement (DTA) or Transfer Specification
for 3rd party vendors in support of Clinical Trial.
- Perform training associated with integration activities for
EDC, eCOA, PK, LAB, BIOMARKER, and IMAGING data.
- 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.
- Secures 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. CORE ELEMENTS RELATED TO THIS ROLE
- Is accountable for system delivery life cycle, including
deployment strategies, user training and management.
- Acts as a primary business change agent to ensure adoption of
new capabilities and business process
- Serves 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
- Leads study level technology & vendor oversight
- Acts as a process expert for operational and oversight
- Confirms archival and inspection readiness of all Clinical
Technology Trial Master File (TMF) documents.
- Participates in preparing function for submission readiness and
may represent Clinical Trial Tools & Technologies (CT3) group in a
formal inspection or audit.
- Follow designated strategy for study level technology &
deployment and defines vendor oversight activities.
- Performs other duties as assigned.CORE ELEMENTS RELATED TO THIS
ROLE The person in this role should have the following experience:
- Project management skills and experience managing
implementation of integrations or implementation of clinical
technologies like eCOA, IRT, EDC, Medical Devices, and Clinical
Data Wearhouse for large drug development programs.
- Working knowledge and understanding of FDA and ICH regulations
and industry standards and quality control principles.
- Solid experience applying System Development Life Cycle (SDLC)
and developing strategies to address required changes to clinical
trial technologies due to evolving GXP regulations.
- Experience with all phases of drug development.Leadership
- Moderate supervision required, should be able to function
collaboratively (with some guidance) with all levels of
employeesDecision-making and Autonomy
- May lead study level negotiation and agreement for data
transfer or integration on behalf of Takeda.Interaction
- Participate on complex, cross-organization technology and
business process projects.
- Drive project delivery in complex matrix organizationInnovation
- Ability to identify new innovative trends in technology to
better support clinical trials
- Support implementation of innovative solution in
- High complexity at program that include multiple projects
- Domestic/international travel (5-20%) to other Takeda sites,
strategic partners, and therapeutic area events may be
required.EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS/BA required or MS preferred in a health-related, life
science area or technology-related fields.
- Minimum of 6 years drug development experience.COMPENSATIONBase
Salary Range: $102,200 to $146,000 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.This
posting is made in compliance with Colorado's Equal Pay for Equal
Work Act, C.R.S. - 8-5-101 et seq.This position is currently
classified as "remote" in accordance with Takeda's Hybrid and
Remote Work policy. 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.LocationsUSA - MA - VirtualWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Rochester , Manager, Third Party Data Integration (REMOTE), Executive , Rochester, New York
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