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Job Description

Senior Clinical Study Associate

Location: Warsaw, Poland (Office-Based/Hybrid) Global Clinical Development Operations (GCDO)

About the Role

At Takeda, we are committed to transforming patient care through the development of innovative medicines. We are seeking a Senior Clinical Study Associate (Sr CSA) to join our Global Clinical Development Operations (GCDO) team in Warsaw, Poland.

As a key member of the Study Management team, you will support the operational execution of global clinical studies within a designated therapeutic area. Working closely with Clinical Study Managers (CSMs), Clinical Operations Program Leads (COPLs), and Study Execution Teams (SETs), you will play an essential role in delivering clinical studies in accordance with development plans, regulatory requirements, and Takeda standards.

This position is ideally suited to a proactive, detail-oriented clinical operations professional who thrives in a collaborative global environment and enjoys driving operational excellence across complex clinical studies.

Key Responsibilities

Study Execution & Operational Delivery

• Proactively manage day-to-day clinical study activities, ensuring compliance with study protocols, ICH-GCP guidelines, and Takeda SOPs.
• Support medium to high complexity global clinical studies, with responsibility for one or more studies and/or programs.
• Collaborate closely with Clinical Study Managers and Study Execution Team members to deliver study objectives and timelines.
• Anticipate operational needs, identify risks, and contribute to effective issue resolution.
• Ensure study activities are executed in alignment with study-specific plans and the established operating model.

Study Start-Up & Site Activation

• Support study start-up activities and site initiation processes.
• Track site activation progress and escalate issues when required.
• Review Site Initiation Visit (SIV) reports and Essential Document Packages (EDP) in collaboration with Study Start-Up teams where applicable.
• Assist with the review and maintenance of study plans, documents, and operational deliverables.

Clinical Systems & Documentation

• Maintain and update clinical trial systems and study documentation on behalf of the Clinical Study Manager.
• Ensure accuracy and completeness across systems such as: Clinical Trial Management Systems (CTMS) Electronic Trial Master File (eTMF) COMPASS and other study platforms
• Support inspection readiness activities by overseeing delegated tasks and ensuring documentation quality.

Vendor & Stakeholder Management

• Contribute to sponsor oversight and vendor management activities.
• Review site monitoring visit reports.
• Track vendor deliverables and study budgets under the guidance of the Clinical Study Manager.
• Collaborate cross-functionally with internal and external stakeholders to support study objectives.

Study Close-Out & Inspection Readiness

• Support study close-out activities, including: Documentation finalization Financial reconciliation Submission-support activities such as data review
• Lead delegated close-out activities independently where appropriate.
• Support audit preparation, participation, and inspection readiness initiatives.
• Contribute to regulatory inspection preparations and attendance when required.

Continuous Improvement & Team Development

• Identify operational risks, process gaps, and opportunities for improvement.
• Escalate issues appropriately to ensure continuity of study operations.
• Act as a subject matter expert within the CSA community.
• Support onboarding, training, mentoring, and knowledge-sharing initiatives.
• Contribute to department-wide and cross-functional projects as required.

What You'll Bring

Education

• Bachelor's degree in Life Sciences, Health Sciences, Technology, or a related discipline.
• Equivalent combinations of education, training, and experience will also be considered.

Experience

• Minimum 2-4 years of experience within the pharmaceutical industry, clinical research organization (CRO), or a related clinical research environment.
• Experience supporting Phase II and/or Phase III clinical studies.
• Experience working on global clinical trials.
• Exposure to multiple therapeutic areas; oncology experience is advantageous.

Technical Knowledge

• Strong understanding of: ICH-GCP Global clinical research regulations Clinical trial compliance requirements
• Experience working with: CTMS eTMF platforms Other clinical trial technology systems
• Understanding of vendor oversight and inspection readiness processes.

Skills & Competencies

• Excellent organizational and task management skills.
• Strong problem-solving and critical thinking abilities.
• Effective stakeholder management and cross-functional collaboration skills.
• Strong written and verbal communication skills.
• Ability to work independently while contributing to a global team environment.
• Demonstrated initiative, adaptability, and a solutions-focused mindset.
• Commitment to quality, compliance, and operational excellence.

Languages

• Fluent written and spoken English.

Locations

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