Manager, IRT Lead
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: May 12, 2022
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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 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 DescriptionIRT Manager is
responsible for the implementation of the Interactive Response
Technologies (IRT) for the clinical trials.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. Key Accountabilities* 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 quality.* Leads study level technology & vendor oversight
activities. * Acts as a process expert for operational and
oversight models.* 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. Educational
Qualifications* BS/BA required preferably in a health-related, life
science area or technology-related fields. Experience* 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. Special Skills/Abilities* Advanced knowledge of
office software (Microsoft Office).* Ability to handle multiple
development programs simultaneously. Behavioral Competencies* 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 skills. Job Complexity* May be
responsible for supervising a small group of contractors.* Medium
complexity projects, or platforms.* Occasional
domestic/international travel to other Takeda sites, strategic
partners, and therapeutic area events may be required. Supervision*
Moderate supervision required, should be able to function
collaboratively (with some guidance) with all levels of
employees.Location: Cambridge - VirtualBase 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 excludedThis posting is made in compliance with Colorado's
Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seqEEO
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.LocationsPennsylvania - VirtualWorker TypeEmployeeWorker
Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Cherry Hill , Manager, IRT Lead, Executive , Cherry Hill, New Jersey
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