Lead Clinical Study Manager - Global Trials & Strategy

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

Job summary

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

You will chair the Study Execution Team, oversee CROs, manage budgets, and mitigate risks while supporting feasibility and regulatory readiness across global studies.

Qualifications

• Bachelor’s degree in life sciences or related field.
• 6+ years in clinical research with global study management experience.
• Proven leadership in cross-functional matrix environments.
• Strong knowledge of ICH-GCP, EU CTR, US CFR.
• Excellent project management and stakeholder skills.
• Fluent English (written and spoken).

Responsibilities

• Lead operational planning, strategy, and execution of assigned clinical studies.
• Chair Study Execution Team to meet timelines, budget, and quality standards.
• Oversee CROs and vendors ensuring Takeda standards.
• Provide operational input into study protocols and related documents.
• Lead study budget planning and oversight of external spend.
• Identify and mitigate study risks; escalate as needed.
• Support country and site feasibility and selection processes.
• Ensure studies are inspection-ready and support inspections.
• Mentor study management team and contribute to initiatives.

Skills

Cross-functional leadership

Global study management

Project management

Regulatory knowledge

Stakeholder management

Fluent English

Education

Bachelor’s degree in life sciences

Job description

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

You will chair the Study Execution Team, oversee CROs, manage budgets, and mitigate risks while supporting feasibility and regulatory readiness across global studies.