Global Clinical Study Lead — Strategy & Delivery

Takeda Pharmaceutical Co.; Łódź; Hybrid; PLN 253,000 - 347,000; Full time

Benefits offered by this job

Hybrid work model

Job summary

Takeda is seeking a Lead Clinical Study Manager (CSM) to drive the operational strategy and execution of clinical studies across assigned programmes. You will lead cross-functional study teams and collaborate with internal stakeholders and external vendors to ensure high-quality, compliant studies delivered on time and within budget.

You will chair the Study Execution Team (SET), oversee CROs and partners, contribute to study protocols, and manage budgets in collaboration with Finance and

Qualifications

• Bachelor’s degree in life sciences or related field.
• 6+ years in clinical research/pharmaceutical industry with strong experience in clinical study management or oversight; global studies preferred.
• Proven ability to lead cross-functional teams in a matrix environment.
• Strong knowledge of global clinical regulations (ICH-GCP, EU CTR, US CFR).
• Excellent project management, problem-solving, and organisational skills.
• Strong communication and stakeholder management capabilities.
• Fluent English (written and spoken).

Responsibilities

• Lead the operational planning, strategy, and execution of assigned clinical studies or programmes.
• Chair and drive the Study Execution Team (SET) to deliver study objectives within timelines, budget, and quality standards (ICH-GCP and Takeda SOPs).
• Oversee CROs, strategic partners, and third-party vendors, ensuring performance and compliance with Takeda standards.
• Provide operational input into study protocols and related documentation, ensuring feasibility and alignment with programme strategy.
• Lead study budget planning and oversight of external spend with Finance and Programme Leadership.
• Identify, manage, and mitigate study risks, escalating issues as needed.
• Support country and site feasibility and selection processes, aligning with study strategy.
• Ensure studies are inspection-ready at all times, supporting regulatory inspections when required.
• Mentor and support study management team members and contribute to initiatives.

Skills

Cross-functional leadership

Project management

Regulatory knowledge

Stakeholder management

Communication

English fluency

Education

Bachelor's degree

Job description

Takeda is seeking a Lead Clinical Study Manager (CSM) to drive the operational strategy and execution of clinical studies across assigned programmes. You will lead cross-functional study teams and collaborate with internal stakeholders and external vendors to ensure high-quality, compliant studies delivered on time and within budget.

You will chair the Study Execution Team (SET), oversee CROs and partners, contribute to study protocols, and manage budgets in collaboration with Finance and