Sr. Manager, Clinical Information Operations-IRT Lead

Job Description

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Job Description

Title

Sr. Manager Clinical Information Operations IRT Lead

Location

Lexington, MA or 100% Virtual

Overview

CDS engages in strategic partnerships, overseeing expert CROs to ensure successful execution and delivery of Clinical Data. CDS also owns Takeda's strategy for the development and governance of Data Standards, and oversight of all Study-level data capture (e.g., EDC, IVR, ePRO, eCOA, CDW) technologies and other related vendors and applications.

As the Clinical Information Operations Sr. Manager, reporting to the Head of Clinical Information Operations, you will participate in, and provide leadership for the following activities:

Key Accountabilities

• Develop strategy for technology selection and deployment across Clinical Studies with established Takeda SOPs and Policies, and governance models.
• Implement new integrations or upgrades to existing IRT platforms for Takeda studies. You will ensure that this activities are performed in GCP compliant way. You will make sure that the system provides intended functionality and appropriate processes are developed to support clinical trial.
• Identify new cost-effective IRT solutions to support clinical program goals. You will work with business representatives from study teams, CROs, vendors and Clinical Supplies organization to ensure delivery of solutions.
• Manage a team of contractors to ensure daily administration of IRT platforms. Working with partners to guide adoption and optimization of implementation of IRT for clinical trials.
• Coordination and participation with external parties (Vendors and CROs)
• Participate in IRT vendor governance meetings to review Goals and Service level agreements.
• Oversee system delivery life cycle, including deployment strategies, user training and management.
• Be 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 Information Operations (CIO) group in a formal inspection or audit.
• Establish major data management study deliverables and develop study metrics, and monitor risk mitigation plans.

Educational Qualifications

BS/BA required or MS preferred in a health-related, life science area or technology-related fields.

Experience

• Minimum of 8 years drug development experience.
• Experience with clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Solid system admin expertise, user support experience in multiple types of clinical 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).
• Project management experience managing implementation of Clinical Data Wearhouse for large drug development programs.
• Experience with all phases of drug development.
• Solid experience applying System Development Life Cycle (SDLC) and developing strategies to address required changes to clinical trial technologies because of evolving GXP regulations.
• Knowledge of FDA and ICH regulations and industry standards and quality control principles.

Base Salary Range: $140,000-170,000 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.

Effective November 1, 2021, 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. As of the same date, absent an approved religious or medical reason, US field-based employees, employees must be fully vaccinated in order to continue in their current roles. 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. Candidates are encouraged to speak with their recruiter to seek further information on the applicable guidelines for the Business Unit/Function for which they have applied.

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.

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.

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