Global Clinical Study Manager: Lead Complex Trials

Takeda; Województwo mazowieckie; In loco; PLN 213.000 - 293.000; Tempo pieno

Descrizione del lavoro

Takeda in Warsaw seeks an experienced Clinical Study Manager to join Global Clinical Development Operations. You will oversee operational planning, delivery and oversight of global clinical studies, ensuring quality, timelines and budget adherence.

You will lead Study Execution Teams, manage CROs, support feasibility, and collaborate with Data Management, Statistics and Regulatory to ensure timely delivery and inspection readiness on a global scale.

Competenze

• Bachelor's degree in Life Sciences or related discipline; or equivalent.
• 5+ years in pharma/CRO with 3+ years in study management/oversight.
• Experience supporting global/ international clinical studies.

Mansioni

• Lead and participate in cross-functional Study Execution Teams (SETs).
• Plan, oversee and deliver clinical trials in compliance with ICH-GCP and regulations.
• Provide operational input into protocol development and study docs.
• Drive feasibility assessments including site burden evaluation.
• Support country/site feasibility and contribute to study planning.
• Develop and implement operational strategies with risk mitigation.
• Manage study timelines, budgets and external spend.
• Oversee CROs and external vendors with sponsor oversight.
• Escalate operational risks and vendor performance concerns.
• Collaborate with DM, Statistics and Regulatory for alignment.
• Ensure studies remain inspection-ready and support inspections.
• Facilitate onboarding of study team members and partners.

Conoscenze

Project management

Stakeholder management

Communication skills

Prioritization

Team collaboration

English fluency

Formazione

Bachelor's degree in Life Sciences / related

Master's or Doctorate (preferred)

Descrizione del lavoro

Takeda in Warsaw seeks an experienced Clinical Study Manager to join Global Clinical Development Operations. You will oversee operational planning, delivery and oversight of global clinical studies, ensuring quality, timelines and budget adherence.

You will lead Study Execution Teams, manage CROs, support feasibility, and collaborate with Data Management, Statistics and Regulatory to ensure timely delivery and inspection readiness on a global scale.