Senior Global Clinical Study Lead

Takeda Pharmaceutical Co.; Warszawa; In loco; PLN 213.000 - 293.000; Tempo pieno

Descrizione del lavoro

Takeda Pharmaceutical Co. in Warsaw, Poland, seeks an experienced Clinical Study Manager (CSM) to join the Global Clinical Development Operations team.

You will lead cross-functional study execution, ensure delivery to ICH-GCP standards, and manage timelines and budgets for global trials. You will partner with Data Management, Statistics, and Regulatory to optimize study delivery, provide operational input on protocols, and drive risk management and vendor oversight in a complex global

Competenze

• 5+ years' experience in the pharmaceutical industry and/or CRO, including 3+ years of clinical study management/oversight experience.
• Significant clinical trial management support experience (e.g., CTA, CRA) and experience on global/international studies.
• Knowledge of global clinical research regulations and compliance (ICH-GCP, EU CTR, US CFR) and local country requirements.

Mansioni

• Lead cross-functional Study Execution Teams (SETs) for assigned studies.
• Plan, oversee and deliver trials in compliance with ICH-GCP and regulations.
• Provide operational input into protocol development and study documents.
• Drive feasibility assessments including site/patient burden analysis.
• Oversee CROs and vendors with sponsor oversight and risk management.
• Ensure studies are inspection-ready and support regulatory inspections when required.

Conoscenze

Project and programme management

Stakeholder management

Communication skills

Organizational & analytical skills

Collaboration & teamwork

English proficiency

Formazione

Bachelor's degree in Life Sciences or related discipline

Descrizione del lavoro

Takeda Pharmaceutical Co. in Warsaw, Poland, seeks an experienced Clinical Study Manager (CSM) to join the Global Clinical Development Operations team.

You will lead cross-functional study execution, ensure delivery to ICH-GCP standards, and manage timelines and budgets for global trials. You will partner with Data Management, Statistics, and Regulatory to optimize study delivery, provide operational input on protocols, and drive risk management and vendor oversight in a complex global