Clinical Operations Manager

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Introduction

The job position of Clinical Operations Manager at Takeda invites ambitious candidates to contribute to meaningful healthcare solutions by leading clinical studies. As a pivotal member of the Clinical Operations Leadership team, you will help steer operational strategies in a company recognized for its innovative drive and commitment to patient-centered approaches. As a Global Top Employer, Takeda emphasizes empowering its workforce, endorsing a culture that prioritizes diverse and inclusive work environments.

Job Goals

In this role, the Clinical Operations Manager is responsible for planning and managing the execution of clinical studies for designated clinical programs. You will work closely with Clinical Operations Program Leads and oversee studies to ensure adherence to quality standards, local regulations, ICH GCP, and Takeda SOPs—all while maintaining project timelines and budget compliance.

Key Responsibilities

The role encompasses a wide array of responsibilities that directly contribute to the success of clinical programs. Key duties include:

• Operational Strategy: Lead the operational planning for assigned clinical trials, engaging with study teams to ensure the feasibility of protocols, budgets, and timelines.
• Collaboration: Work in close contact with Strategic Partners, Contract Research Organizations (CROs), and other vendors to maintain the integrity of study execution and business objectives.
• Oversight and Management: Review and approve essential monitoring documents while participating in regular team meetings to ensure continuous alignment.
• Budget Management: Responsible for financial planning, you will maintain regular communications with various stakeholders to ensure transparency around spending, enrollment, and project progress.

Required Skills and Qualifications

Takeda seeks candidates with a solid educational background and relevant professional experience:

• Education: A BS/BA in a health-related, life science, or technology field is required. Advanced degrees (Masters or Doctorates) may supplement experience requirements.
• Experience: A minimum of 5 years of experience within the pharmaceutical industry or clinical research is necessary, including at least 3 years in clinical study management. Familiarity with global studies and various therapeutic areas is a plus.
• Regulatory Knowledge: Proficiency in global regulatory and compliance mandates such as US CFR, EU CTD, and ICH GCP is essential. Awareness of local country regulations will be beneficial.
• Skills: Strong communication, project management, and organizational skills are required. The ability to work collaboratively within cross-functional teams is also important.

Salary and Benefits

The U.S. Base Salary Range for this position is estimated to be between $99,500.00 - $156,420.00. This range reflects various factors such as qualifications, relevant experience, and education. Takeda is dedicated to equitable pay practices and ensures that the actual salary aligns with state or local minimum wage requirements.

In addition to competitive pay, U.S.-based employees are eligible for various benefits, including:

• Health Insurance: Medical, dental, and vision plans.
• Retirement Plans: 401(k) plan with company matching.
• Leave Benefits: Up to 120 hours of paid vacation and 80 hours of sick time per year, along with paid volunteer time.
• Other Perks: Tuition reimbursement, long-term disability coverage, and well-being benefits.

Application Process

To apply for the Clinical Operations Manager role at Takeda, click the Apply button associated with the listing. The application process is straightforward, and candidates will be required to provide their personal information while acknowledging Takeda's Privacy Notice. Ensure that all information is submitted truthfully, as it is essential for the application review.

Conclusion

This opportunity to work with Takeda not only allows you to engage in innovative healthcare practice but also offers the chance to be part of a mission that is focused on enhancing patient outcomes. The managerial position is ideal for individuals passionate about clinical operations in the healthcare sector, offering career development within a respected organization that values diversity and inclusion.

This job offer was originally published on himalayas.app