Senior Clinical Study Associate, Global Operations

USA - 3316 Takeda Development Center Americas, Inc.

Warszawa

Hybrid

PLN 150,000 - 230,000

Full time

4 days ago
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Job summary

Takeda is seeking a Senior Clinical Study Associate for our Global Clinical Development Operations team in Warsaw, Poland. You will support the operational execution of global studies, working with Clinical Study Managers, COPLs, and SETs to ensure timelines and regulatory requirements are met.

Ideal candidates have 2–4 years in clinical research, global study experience, and strong ICH-GCP knowledge. This hybrid role offers collaboration across a multinational environment and contributes to

Qualifications

  • Bachelor's degree in Life Sciences, Health Sciences, Technology, or related discipline.
  • Minimum 2–4 years of pharma/ CRO clinical research experience.
  • Experience supporting Phase II and/or Phase III global studies.
  • Exposure to multiple therapeutic areas; oncology experience is advantageous.

Responsibilities

  • Proactively manage day-to-day clinical study activities in line with ICH-GCP and Takeda SOPs.
  • Support study start-up activities and site activation processes.
  • Maintain and update CTMS, eTMF, and other study documentation.
  • Collaborate with Clinical Study Managers and SETs to deliver study objectives and timelines.
  • Contribute to sponsor oversight, vendor management, and inspection readiness.

Skills

Organizational skills
Problem solving
Stakeholder management
Communication
Independence
Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Tools

CTMS
eTMF
Clinical trial software

Job description

Takeda is seeking a Senior Clinical Study Associate for our Global Clinical Development Operations team in Warsaw, Poland. You will support the operational execution of global studies, working with Clinical Study Managers, COPLs, and SETs to ensure timelines and regulatory requirements are met.

Ideal candidates have 2–4 years in clinical research, global study experience, and strong ICH-GCP knowledge. This hybrid role offers collaboration across a multinational environment and contributes to

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