Manager, IRT Lead

Company: Takeda Pharmaceutical
Location: Pleasantville
Posted on: May 13, 2022

Job Description:

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Job Description
IRT 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 - 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

EEO Statement
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.

Locations
Pennsylvania - Virtual

Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time

Keywords: Takeda Pharmaceutical, Yonkers , Manager, IRT Lead, Executive , Pleasantville, New York