Senior Clinical Study Specialist - Global Trials, Warsaw

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

Job summary

Takeda Pharmaceutical Co. in Warsaw, Poland, is seeking a Senior Clinical Study Associate to join our Global Clinical Development Operations (GCDO) team.

The role focuses on operational delivery of global clinical studies, collaborating with CSMs, COPLs, and SETs to meet development plans and regulatory requirements. The ideal candidate has 2–4 years in clinical research, experience with Phase II/III trials, and strong ICH-GCP knowledge; oncology exposure is a plus in a global, hybrid-office

Qualifications

• Bachelor's degree in Life Sciences, Health Sciences, Technology, or a related discipline.
• Equivalent combinations of education, training and experience will be considered.
• Minimum 2–4 years in the pharmaceutical industry, CRO, or related clinical research environment.
• Experience supporting Phase II and/or Phase III clinical studies.
• Experience working on global clinical trials; oncology experience advantageous.

Responsibilities

• Proactively manage day-to-day clinical study activities per protocol and ICH-GCP guidelines.
• Support medium to high complexity global clinical studies with responsibility for studies/programs.
• Collaborate with Clinical Study Managers and SETs to deliver objectives and timelines.
• Track start-up activities and site activations; elevate issues as needed.
• Maintain and update study documentation across CTMS, eTMF, COMPASS and other systems.
• Support sponsor oversight, vendor management, and study budgets.

Skills

Organizational skills

Cross-functional collaboration

Problem-solving

Clear communication

Independent work

Education

Bachelor's degree in Life Sciences/Health Sciences/Technology

Tools

CTMS

eTMF

COMPASS

Job description

Takeda Pharmaceutical Co. in Warsaw, Poland, is seeking a Senior Clinical Study Associate to join our Global Clinical Development Operations (GCDO) team.

The role focuses on operational delivery of global clinical studies, collaborating with CSMs, COPLs, and SETs to meet development plans and regulatory requirements. The ideal candidate has 2–4 years in clinical research, experience with Phase II/III trials, and strong ICH-GCP knowledge; oncology exposure is a plus in a global, hybrid-office