Senior Global Clinical Study Lead, Cross-Functional

POL - 6999 Takeda SCE

Łódź

Hybrid

PLN 253,000 - 347,000

Full time

3 days ago
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Job summary

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

The role requires a bachelor’s degree in life sciences, 6+ years in clinical research with global study oversight, and strong knowledge of ICH-GCP, EU

Qualifications

  • Bachelor’s degree in life sciences or related field.
  • 6+ years in clinical research/pharma with strong 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 organizational skills.
  • Strong communication and stakeholder management abilities.
  • Fluent English (written and spoken).

Responsibilities

  • Lead planning, strategy, and execution of assigned clinical studies.
  • Chair the SET to meet timelines, budget, and quality (ICH-GCP, Takeda SOPs).
  • Oversee CROs and vendors for performance and compliance.
  • Provide operational input on study protocols and docs.
  • Lead study budgets and external spend with Finance.
  • Identify and mitigate study risks; escalate as needed.
  • Support country/site feasibility and selection.
  • Ensure readiness for regulatory inspections.
  • Mentor study management team members and help initiatives.

Skills

Cross-functional leadership
Global trials oversight
Project management
Stakeholder management
English fluency

Education

Bachelor’s degree in life sciences
6+ years clinical research experience

Job description

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

The role requires a bachelor’s degree in life sciences, 6+ years in clinical research with global study oversight, and strong knowledge of ICH-GCP, EU

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