Sr. Manager, Clinical Trial Configuration

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Job Description

ACCOUNTABILITIES

• Leads in the deployment of technologies and business process across the CDS organization.
• Establishment and support of business process SOPs
• Accountable for system delivery life cycle in collaboration with appropriate stakeholders including but not limited to Clinical Operations, DD&T, and Quality organizations
• Acts as a primary business change agent to ensure adoption of new capabilities and business process
• Lead with appropriate stakeholders to establish technology standards and governance models
• Clinical Technology SME in Clinical Study Team accountable for:

• Serves as the first point of contact for implementation of Clinical Technologies like eCOA,  eConsent, Telehealth, Devices or licensing of COA instruments
• Collaborates with leaders of supported business functions to identify and resolve issues impacting the delivery of clinical trials
• Acts as a process expert for operational and oversight models
• Participates in study level technology vendor oversight activities

• Other duties as assigned

CORE ELEMENTS RELATED TO THIS ROLE

• Develops strategy for technology selection and deployment 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 required representation of Clinical Trial Configuration (CTC) 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.

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 with direct clinical technology experience.

This position is currently classified as “remote” by Takeda’s Hybrid and Remote Work policy

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. 

For Location:

Massachusetts - Virtual

U.S. Base Salary Range:

$137,000.00 - $215,270.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. 

U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation. 

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

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

Job Exempt

Yes

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.