Senior Clinical Study Lead – Global Operations

Takeda Pharmaceutical Co.; Warszawa; Hybrid; PLN 128,000 - 176,000; Full time

Job summary

Takeda Pharmaceutical Co. invites a Senior Clinical Study Associate to join the Global Clinical Development Operations team in Warsaw, Poland.

You will support operational delivery of global clinical studies, collaborating with CS Managers, COPLs, and SETs to meet development plans and regulatory requirements. Ideal candidates have 2–4 years in pharma/ CRO, strong ICH-GCP knowledge, and experience with Phase II/III trials and global studies.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 2–4 years in pharma/ CRO or related clinical research.
• Experience with Phase II/III and global clinical trials.

Responsibilities

• Proactively manage day-to-day clinical study activities in line with protocols and ICH-GCP.
• Support start-up activities and site activation tracking progress.
• Maintain and update CTMS/eTMF and other study documentation.
• Contribute to vendor oversight, study budgets, and cross-functional collaboration.
• Support inspection readiness and regulatory inspection preparations.

Skills

Organizational skills

Stakeholder management

Cross-functional collaboration

Communication skills

Global teamwork

Education

Bachelor's degree in Life Sciences or related field

Tools

CTMS

eTMF

COMPASS

Job description

Takeda Pharmaceutical Co. invites a Senior Clinical Study Associate to join the Global Clinical Development Operations team in Warsaw, Poland.

You will support operational delivery of global clinical studies, collaborating with CS Managers, COPLs, and SETs to meet development plans and regulatory requirements. Ideal candidates have 2–4 years in pharma/ CRO, strong ICH-GCP knowledge, and experience with Phase II/III trials and global studies.