Manager, IRT Lead
Company: Takeda Pharmaceutical
Posted on: May 14, 2022
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IRT Manager is responsible for the implementation of the
Interactive Response Technologies (IRT) for the clinical
Manager, Clinical Information Operations
* The Manager, -Clinical Information Operations is responsible for
timely and high-quality delivery of systems and documentation in
support of Clinical studies. -He/she conducts oversight of
implementation, operation, and close-out of Clinical system(s)
activities performed by Strategic Partners and/or other CROs and
other 3rd party vendors to meet Takeda's obligations described in
ICH-GCP and Takeda's business objectives.
* The Manager, -Clinical Information Operations contributes to the
management of vendor partnerships to verify contractual assumptions
in the study SOWs. -He/she provides consulting services to Clinical
study teams with technology and vendor selection to successfully
achieve study goals.
* The Manager, -Clinical Information Operations maintains, serves
as an expert for clinical technologies best practices. -He/she acts
as a first point of contact for CRO partners seeking sponsor input
on study level problem solving and decision making.
* Identifies, deploys and provides technology support across
Clinical Studies in alignment with established Takeda SOPs &
Policies, and governance models.
* 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 activities.
* 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 Information Operations (CIO) group in a
formal inspection or audit.
* Tracks major data management study deliverables and milestones,
evaluates study metrics to define risk mitigation plans.
* Performs other duties as assigned.
* BS/BA required preferably in a health-related, life science area
or technology-related fields.
* Minimum of 6 years drug development experience.
* Solid understanding of clinical trial documents (protocols,
statistical analysis plans, CRFs, study reports) and processes.
* Proven track record of strong project management skills and
experience managing implementation of eCOA, IRT, EDC, Clinical Data
Wearhouse or CTMS for large drug development programs.
* Experience with all phases of drug development.
* Working knowledge and understanding of FDA and ICH regulations
and industry standards and quality control principles.
* Good system admin expertise, working/user knowledge with at least
one of the following technologies: electronic Clinical Outcome
Assessment (eCOA), electronic Patient Reported Outcome (ePRO),
Interactive Voice/Web Response System (IxRS), Electronic Data
Capture (EDC), Clinical Data Wearhouse , or Clinical Trial
Management System (CTMS).
* Good understanding of System Development Life Cycle (SDLC) and
ability to evaluate impact due to changes in GXP regulations.
* Advanced knowledge of office software (Microsoft Office).
* Ability to handle multiple development programs
* Is comfortable with ambiguity.
* Excellent teamwork, organizational, interpersonal, conflict
resolution and problem-solving skills.
* Entrepreneurial and innovative; takes measured risks; thinks
outside the box; challenge the status quo.
* Demonstrated strong matrix leadership and communication
* May be responsible for supervising a small group of
* Medium complexity projects, or platforms.
* Occasional domestic/international travel to other Takeda sites,
strategic partners, and therapeutic area events may be
* Moderate supervision required, should be able to function
collaboratively (with some guidance) with all levels of
Location: Cambridge - Virtual
Base Salary Range: $120,000-$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 excluded
This posting is made in compliance with Colorado's Equal Pay for
Equal Work Act, C.R.S. - 8-5-101 et seq
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.
Pennsylvania - Virtual
Keywords: Takeda Pharmaceutical, Paterson , Manager, IRT Lead, Executive , Mahwah, New Jersey
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