Sr. Manager, Clinical Trial Configuration

Takeda

2d • $137,000 - $215,270 • Remote

About The Position

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 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.

Requirements

• 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.

Responsibilities

• 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
• 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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level