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

Are you looking for a patient-focused, innovation-driven company to inspire you and empower you to shine? Join us as a Senior Clinical Trial Associate based remotely reporting to the Clinical Trial Associate Manager.

At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to accomplish their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and work toward excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.

Here, you will be an important contributor to our inspiring, bold mission.

GOALS:

The remote-based Senior Clinical Trial Associate (CTA) will independently perform tasks related to supporting operational strategy and planning clinical studies, supporting the strategy as defined in the Clinical Development Plan.

• Provide support for essential daily clinical study activities, including inspection readiness and oversight of inspection deliverables, following established protocols under the general guidance of the Clinical Trial Associate Manager.

• Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.

• Perform departmental tasks, including being an expert or overseeing projects; act as mentor to junior Clinical Trial Associate team members.

• Perform developmental tasks with oversight of the Clinical Trial Associate Manager.

ACCOUNTABILITIES:

For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including:

• Approval of study documentation, including essential document packets, study plans, informed consent forms.

• Support oversight of risk-based monitoring.

• Attendance of essential team meetings; may make presentations (e.g. data, resourcing, projects).

• Support regulatory inspection readiness (e.g. prepare inspection materials, participate during regulatory inspections, and oversee deliverables during regulatory inspections).

• Support additional ad-hoc activities, as agreed with the Clinical Trial Associate Manager.

• Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors.

• Escalate clinical trial insurance issues.

• Support Health Care Provider Engagement for facilitating contracts and meetings.

• Support vendor contract administration.

• Maintain knowledge and acts as team super-user or expert for related systems; provide presentations, training, and support to Clinical Trial Associate Team; provide updates to applicable Clinical Trial Associate resources.

• Lead functional programs and working groups.

• Career development and goal setting.

• Targeted skill development of knowledge base.

EDUCATION AND EXPERIENCE:

• Bachelor's Degree or equivalent international degree.

• 2 or more years or experience in pharmaceutical industry, clinical research organization, or related role.

• Experience working on Phase 2 and 3 studies and global/international studies is advantageous.

• Experience working across multiple therapeutic areas is advantageous.

• Knowledge in global regulatory and compliance requirements for clinical research.

• Excellence in task management and collaboration.

Additional Information:

• Up to 10% travel, including in-person attendance at designated Takeda offices based on business need

WHAT TAKEDA CAN OFFER YOU:

• Base Salary Range: $79,800 to $114,000, based on candidate professional experience level. Employees may also be eligible for Short Term benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement 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.

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

Worker Type

Worker Sub-Type

Time Type