Senior Clinical Study Associate — Global Trials (Warsaw)

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

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