Senior Clinical Study Manager – Global Programs

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

Benefits offered by this job

Hybrid working model

Job summary

Takeda is seeking a Lead Clinical Study Manager (CSM) to drive the operational strategy and execution of clinical studies across assigned programmes in Lodz, Poland. You will lead cross-functional study teams and partner with internal stakeholders and vendors to deliver high-quality studies on time and within budget.

The role requires a Bachelor’s degree in life sciences and 6+ years in clinical research, with global study experience preferred.

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
• Ability to lead cross-functional teams in a matrix environment
• Strong knowledge of global clinical regulations (ICH-GCP, EU CTR, US CFR)
• 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 related documentation
• Lead study budget planning and oversight of external spend with Finance and Programme Leadership
• Identify and mitigate study risks and escalate issues appropriately
• Support country and site feasibility and selection processes
• Ensure studies are inspection-ready at all times for regulatory inspections
• Mentor and support study management team members

Skills

Cross-functional leadership

Project management

Stakeholder management

Regulatory knowledge

Fluent English

Education

Bachelor's degree in life sciences

Job description

Takeda is seeking a Lead Clinical Study Manager (CSM) to drive the operational strategy and execution of clinical studies across assigned programmes in Lodz, Poland. You will lead cross-functional study teams and partner with internal stakeholders and vendors to deliver high-quality studies on time and within budget.

The role requires a Bachelor’s degree in life sciences and 6+ years in clinical research, with global study experience preferred.