Senior Global Clinical Study Manager | Strategy & Execution

Takeda; Województwo mazowieckie; Hybrid; PLN 253,000 - 347,000; Full time

Job summary

Takeda in Warsaw, Poland is seeking a Lead Clinical Study Manager to drive operational strategy and execution of global clinical studies. You will lead cross-functional study teams and partner with internal stakeholders and external vendors to ensure delivery of high-quality, compliant studies on time and within budget.

This role requires a Bachelor’s degree in life sciences, 6+ years in clinical research, strong leadership in matrix environments, and fluency in English.

Qualifications

• Bachelor's degree in life sciences or related field.
• 6+ years in clinical research/pharma with study management experience.
• 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.
• Fluent English, written and spoken.

Responsibilities

• Lead operational planning, strategy and execution of assigned clinical studies.
• Chair the Study Execution Team to meet timelines, budget, and quality.
• Oversee CROs and vendors ensuring performance and compliance.
• Provide input into study protocols and documentation for feasibility.
• Lead study budget planning and external spend oversight.
• Identify, manage and mitigate study risks and ensure escalation.
• Support country/site feasibility and alignment with study strategy.
• Ensure inspections readiness and support regulatory inspections.
• Mentor study management team members and contribute to initiatives.

Skills

Cross-functional leadership

Project management

Stakeholder management

Problem-solving

Organizational skills

Fluent English

Education

Bachelor's degree in life sciences or related field

Job description

Takeda in Warsaw, Poland is seeking a Lead Clinical Study Manager to drive operational strategy and execution of global clinical studies. You will lead cross-functional study teams and partner with internal stakeholders and external vendors to ensure delivery of high-quality, compliant studies on time and within budget.

This role requires a Bachelor’s degree in life sciences, 6+ years in clinical research, strong leadership in matrix environments, and fluency in English.