Takeda
Overview
Clinical Study Manager at Takeda. This role is remote and reports to the Clinical Operations Leadership team. This range is provided by Takeda. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range: $99,500.00/yr - $156,420.00/yr. By clicking the Apply button, you understand that your employment application process with Takeda will commence and that the information you provide in your application will be processed in line with Takeda’s Privacy Notice and Terms of Use. You further attest that all information you submit in your employment application is true to the best of your knowledge. Job Description: Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team. Takeda is transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. We empower our people to work towards their potential through life-changing work. We are a Global Top Employer, offering stimulating careers and a commitment to Better Health and a Brighter Future worldwide. Here, you will be a necessary contributor to our inspiring mission. GOALS : Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting the clinical strategy defined in the Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s). Responsibilities
Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. Oversee 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. Oversee the planning and operational strategy and execution for assigned clinical trials. Provide subject matter expertise and operational input into protocol synopsis, final protocol and other study-related documents. Challenge study teams to ensure operational feasibility, including patient and site burden; validate budgets and ensure impacts are addressed. Participate in country and site feasibility/selection with country insights, corporate alignment and therapeutic expertise to align study execution with program strategy. Ensure timelines meet the clinical development plan; onboard new team members and vendors; lead development of the Operational Strategy during Early Engagement with Strategic Partner(s) and/or CROs; ensure robust risk management plans. Provide oversight and guidance to Strategic Partners/CROs to address and resolve study issues rapidly. Manage study budgets and external spend; coordinate with Clinical Operations Program Leader(s), Global Program Management, and Finance to maintain budget, enrollment, and gaiting accuracy; communicate study status, costs and issues; escalate to governance as needed. Oversee vendor selection, budget and contract negotiation, and supervision of performance for Strategic Partners/CROs; escalate issues to governance when warranted. Review and approve key monitoring documents/plans; review study plans; manage study team meetings and minutes; monitor protocol deviations to identify trends; monitor risks and implement mitigations. In partnership with data management, review database timelines and ensure linkage between strategy and tactical plans for filing/registration, data generation, database lock and CSR. Ensure studies are inspection-ready at all times and participate in regulatory inspections as needed. Education and Experience
BS/BA required, preferably in a health-related, life science or technology-related field, or equivalent combination of education, training and experience. Advanced degree(s) and relevant training or experience may supplement requirements. 5 or more years’ experience in pharmaceutical industry and/or clinical research organization, including 3 or more years in clinical study management/oversight and significant study management support experience. Experience in early phase or Phase 2/3 studies, global/international studies or programs; experience in more than one therapeutic area is advantageous. Knowledge of global regulatory and compliance requirements for clinical research (e.g., US CFR, EU CTD, ICH GCP); awareness of local country requirements. Demonstrated project/program management and matrix leadership; good communication, teamwork, organizational, interpersonal and problem-solving skills; fluent business English (oral and written). Compensation and Benefits
Takeda Compensation and Benefits Summary: We understand compensation is important when considering the next step in your career. We are committed to equitable pay and transparency in pay practices. Location: Massachusetts - Virtual U.S. Base Salary Range: $99,500.00 - $156,420.00 The actual base salary offered depends on qualifications, experience, skills, education, certifications, and location. Base salary will comply with state or local minimum wage requirements. U.S. based employees may be eligible for short-term and/or long-term incentives, medical/dental/vision insurance, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays and well-being benefits. New hires may accrue up to 120 hours of paid vacation and up to 80 hours of sick time per year. EEO Statement : Takeda is committed to creating a diverse workforce and providing equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, Vietnam-era veteran status, or any other protected status in accordance with applicable laws. Locations: Massachusetts - Virtual Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time Job Exempt: Yes Notes: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Penalties apply for violations.
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Clinical Study Manager at Takeda. This role is remote and reports to the Clinical Operations Leadership team. This range is provided by Takeda. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range: $99,500.00/yr - $156,420.00/yr. By clicking the Apply button, you understand that your employment application process with Takeda will commence and that the information you provide in your application will be processed in line with Takeda’s Privacy Notice and Terms of Use. You further attest that all information you submit in your employment application is true to the best of your knowledge. Job Description: Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Clinical Study Manager based remotely reporting to the Clinical Operations Leadership team. Takeda is transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. We empower our people to work towards their potential through life-changing work. We are a Global Top Employer, offering stimulating careers and a commitment to Better Health and a Brighter Future worldwide. Here, you will be a necessary contributor to our inspiring mission. GOALS : Lead study operational strategy and planning and oversee execution of clinical studies for an assigned clinical program(s), supporting the clinical strategy defined in the Clinical Development Plan. In close collaboration with Clinical Operations Program Lead(s). Responsibilities
Oversee the execution of studies in assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Takeda SOPs), on schedule and on budget. Oversee 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. Oversee the planning and operational strategy and execution for assigned clinical trials. Provide subject matter expertise and operational input into protocol synopsis, final protocol and other study-related documents. Challenge study teams to ensure operational feasibility, including patient and site burden; validate budgets and ensure impacts are addressed. Participate in country and site feasibility/selection with country insights, corporate alignment and therapeutic expertise to align study execution with program strategy. Ensure timelines meet the clinical development plan; onboard new team members and vendors; lead development of the Operational Strategy during Early Engagement with Strategic Partner(s) and/or CROs; ensure robust risk management plans. Provide oversight and guidance to Strategic Partners/CROs to address and resolve study issues rapidly. Manage study budgets and external spend; coordinate with Clinical Operations Program Leader(s), Global Program Management, and Finance to maintain budget, enrollment, and gaiting accuracy; communicate study status, costs and issues; escalate to governance as needed. Oversee vendor selection, budget and contract negotiation, and supervision of performance for Strategic Partners/CROs; escalate issues to governance when warranted. Review and approve key monitoring documents/plans; review study plans; manage study team meetings and minutes; monitor protocol deviations to identify trends; monitor risks and implement mitigations. In partnership with data management, review database timelines and ensure linkage between strategy and tactical plans for filing/registration, data generation, database lock and CSR. Ensure studies are inspection-ready at all times and participate in regulatory inspections as needed. Education and Experience
BS/BA required, preferably in a health-related, life science or technology-related field, or equivalent combination of education, training and experience. Advanced degree(s) and relevant training or experience may supplement requirements. 5 or more years’ experience in pharmaceutical industry and/or clinical research organization, including 3 or more years in clinical study management/oversight and significant study management support experience. Experience in early phase or Phase 2/3 studies, global/international studies or programs; experience in more than one therapeutic area is advantageous. Knowledge of global regulatory and compliance requirements for clinical research (e.g., US CFR, EU CTD, ICH GCP); awareness of local country requirements. Demonstrated project/program management and matrix leadership; good communication, teamwork, organizational, interpersonal and problem-solving skills; fluent business English (oral and written). Compensation and Benefits
Takeda Compensation and Benefits Summary: We understand compensation is important when considering the next step in your career. We are committed to equitable pay and transparency in pay practices. Location: Massachusetts - Virtual U.S. Base Salary Range: $99,500.00 - $156,420.00 The actual base salary offered depends on qualifications, experience, skills, education, certifications, and location. Base salary will comply with state or local minimum wage requirements. U.S. based employees may be eligible for short-term and/or long-term incentives, medical/dental/vision insurance, 401(k) with company match, disability coverage, life insurance, tuition reimbursement, paid volunteer time off, company holidays and well-being benefits. New hires may accrue up to 120 hours of paid vacation and up to 80 hours of sick time per year. EEO Statement : Takeda is committed to creating a diverse workforce and providing equal employment opportunities regardless of race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, Vietnam-era veteran status, or any other protected status in accordance with applicable laws. Locations: Massachusetts - Virtual Worker Type: Employee Worker Sub-Type: Regular Time Type: Full time Job Exempt: Yes Notes: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment. Penalties apply for violations.
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