Senior Clinical Study Lead — Global Programs

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

Job summary

Takeda Pharmaceutical Co. in Warsaw, Poland seeks a Lead Clinical Study Manager to drive operational strategy and execution of clinical studies across programmes. You will lead cross-functional study teams, manage budgets, and ensure studies meet ICH-GCP and Takeda standards.

The role requires a Bachelor’s degree in life sciences, 6+ years in clinical research, and fluent English. The position offers a hybrid working model and global collaboration across functions.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 6+ years in clinical research/pharmaceutical industry, with strong study management experience.
• Global studies experience 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 operational planning, strategy and execution of assigned clinical studies or programmes.
• Chair and drive the Study Execution Team to deliver objectives on time, budget and quality.
• Oversee CROs, strategic partners and vendors for performance and compliance with Takeda standards.
• Provide operational input into study protocols and related documentation.
• Lead study budget planning and oversight of external spend with Finance and Programme Leadership.
• Identify and mitigate study risks; escalate issues as needed.
• Support country and site feasibility and selection aligned with study strategy.
• Ensure studies are inspection-ready and support regulatory inspections when required.
• Mentor study management team members and contribute to functional initiatives

Skills

Cross-functional leadership

Project management

Regulatory knowledge

Stakeholder management

Communication

English proficiency

Education

Bachelor’s degree in life sciences

Job description

Takeda Pharmaceutical Co. in Warsaw, Poland seeks a Lead Clinical Study Manager to drive operational strategy and execution of clinical studies across programmes. You will lead cross-functional study teams, manage budgets, and ensure studies meet ICH-GCP and Takeda standards.

The role requires a Bachelor’s degree in life sciences, 6+ years in clinical research, and fluent English. The position offers a hybrid working model and global collaboration across functions.