Global Clinical Study Leader - Hybrid & Cross-Functional

Takeda; Łódź; Hybrid; PLN 215,000 - 296,000; Full time

Job summary

Takeda in Łódź, 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, oversee CROs and vendors, and ensure studies are compliant, on time, and within budget, with a focus on inspection readiness.

This role offers a hybrid working model with in-office presence in Łódź and opportunities to contribute to Takeda’s global clinical development goals.

Qualifications

• Bachelor’s degree in life sciences or related field.
• Significant experience in clinical research/pharma industry.
• Experience leading cross-functional study teams.
• Knowledge of ICH-GCP and global regulations.

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 in line with timelines, budget, and quality standards (including 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, working closely with Finance and Programme Leadership.
• Identify, manage, and mitigate study risks, ensuring issues are resolved effectively and escalated where appropriate.
• Support country and site feasibility and selection processes, ensuring alignment with overall study strategy.
• Ensure studies are inspection-ready at all times, supporting regulatory inspections where required.
• Mentor and support study management team members and contribute to functional initiatives.

Skills

Cross-functional leadership

Clinical study management

Regulatory knowledge

Project management

Stakeholder management

English fluency

Education

Bachelor's degree in life sciences

Job description

Takeda in Łódź, 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, oversee CROs and vendors, and ensure studies are compliant, on time, and within budget, with a focus on inspection readiness.

This role offers a hybrid working model with in-office presence in Łódź and opportunities to contribute to Takeda’s global clinical development goals.