Lead Clinical Study Manager — Global, Hybrid Role

Takeda; Łódź; On-site; PLN 253,000 - 347,000; Full time

Job summary

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

The role demands a Bachelor’s in life sciences, 6+ years in clinical research, strong regulatory knowledge (ICH-GCP, EU CTR, US CFR), and excellent project management and stakeholder skills.

Qualifications

• Bachelor's degree in life sciences or related field.
• 6+ years in clinical research/pharmaceutical industry, with global study management experience.
• Strong cross-functional leadership in a matrix environment.
• 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 on time, budget and quality.
• Oversee CROs and third-party vendors, ensuring performance and Takeda standards.
• Provide operational input into study protocols and documentation for feasibility and alignment.
• Lead study budget planning and oversight of external spend with Finance and Programme Leadership.
• Identify, manage and mitigate study risks; escalate when appropriate.
• Support country and site feasibility and selection aligned with study strategy.
• Ensure studies are inspection-ready and support regulatory inspections as required.
• Mentor and support study management team members.

Skills

Cross-functional leadership

Project management

Stakeholder management

Communication

Fluent English

Education

Bachelor's degree in life sciences

Job description

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

The role demands a Bachelor’s in life sciences, 6+ years in clinical research, strong regulatory knowledge (ICH-GCP, EU CTR, US CFR), and excellent project management and stakeholder skills.