Senior Clinical Associate

Takeda; Warszawa; Hybrid; PLN 180,000 - 240,000; Full time

Job summary

Takeda in Warsaw, Poland is seeking a Senior Clinical Study Associate to join the Global Clinical Development Operations team. You will manage day-to-day clinical study activities, ensuring compliance with ICH-GCP and Takeda SOPs, and support medium to high complexity studies.

The role covers study start-up, site activation, CTMS/eTMF systems, vendor oversight, and inspection readiness. You bring 2–4 years pharma CRO experience, a Life Sciences degree, and strong collaboration and communication

Qualifications

• Bachelor's degree in Life Sciences or equivalent
• 2–4 years in pharma/ CRO or clinical research environment
• Experience supporting Phase II/III clinical studies
• Experience with global clinical trials and multiple therapeutic areas

Responsibilities

• Proactively manage day-to-day clinical study activities with ICH-GCP compliance
• Support medium to high complexity global studies and collaborate with Study Managers
• Assist start-up, site activation, SIV review and EDP maintenance
• Maintain and update CTMS/eTMF and other trial systems
• Oversee vendor oversight, site monitoring reports, and study budgets
• Support study close-out, inspection readiness, and regulatory submissions
• Mentor and support onboarding of teammates within CSA community

Skills

Organizational skills

Problem solving

Stakeholder management

Communication

Independence

Education

Bachelor's degree in Life Sciences

Equivalent combinations of education/experience

Tools

CTMS

eTMF

COMPASS

Job description

Job Description

Senior Clinical Study Associate

Location: Warsaw, Poland (Office-Based/Hybrid)

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.

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 elevate 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

Warsaw, Poland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time