Clinical Study Manager

Takeda; Województwo mazowieckie; On-site; PLN 213,000 - 293,000; Full time

Job summary

Takeda in Warsaw seeks an experienced Clinical Study Manager to join Global Clinical Development Operations. You will oversee operational planning, delivery and oversight of global clinical studies, ensuring quality, timelines and budget adherence.

You will lead Study Execution Teams, manage CROs, support feasibility, and collaborate with Data Management, Statistics and Regulatory to ensure timely delivery and inspection readiness on a global scale.

Qualifications

• Bachelor's degree in Life Sciences or related discipline; or equivalent.
• 5+ years in pharma/CRO with 3+ years in study management/oversight.
• Experience supporting global/ international clinical studies.

Responsibilities

• Lead and participate in cross-functional Study Execution Teams (SETs).
• Plan, oversee and deliver clinical trials in compliance with ICH-GCP and regulations.
• Provide operational input into protocol development and study docs.
• Drive feasibility assessments including site burden evaluation.
• Support country/site feasibility and contribute to study planning.
• Develop and implement operational strategies with risk mitigation.
• Manage study timelines, budgets and external spend.
• Oversee CROs and external vendors with sponsor oversight.
• Escalate operational risks and vendor performance concerns.
• Collaborate with DM, Statistics and Regulatory for alignment.
• Ensure studies remain inspection-ready and support inspections.
• Facilitate onboarding of study team members and partners.

Skills

Project management

Stakeholder management

Communication skills

Prioritization

Team collaboration

English fluency

Education

Bachelor's degree in Life Sciences / related

Master's or Doctorate (preferred)

Job description

Clinical Study Manager (CSM)

Location: Poland Lodz

Function: Global Clinical Development Operations (GCDO)

Organisation: Global Development Organisation (GDO)

About The Role

We are seeking an experienced Clinical Study Manager (CSM) to join our Global Clinical Development Operations team. As a key member of the study execution team, you will be accountable for the operational planning, delivery and oversight of clinical studies supporting global clinical development programmes. You will work collaboratively with cross-functional stakeholders and external partners to ensure studies are delivered to the highest quality standards, on schedule and within budget. This role offers the opportunity to lead complex global clinical studies, influence operational strategy, and contribute to the development of innovative medicines that make a meaningful difference for patients worldwide.

Key Responsibilities

• Lead and participate in cross-functional Study Execution Teams (SETs) for assigned clinical studies.
• Plan, oversee and deliver clinical trials in compliance with ICH-GCP, applicable regulations and company procedures.
• Provide operational expertise and input into protocol development and study-related documentation.
• Drive operational feasibility assessments, including evaluation of patient and site burden.
• Support country and site feasibility activities and contribute therapeutic and operational expertise to study planning.
• Develop and implement operational strategies, ensuring appropriate risk identification and mitigation plans are in place.
• Manage study timelines, budgets and external spend throughout the study lifecycle.
• Oversee Contract Research Organisations (CROs), strategic partners and external vendors, ensuring effective delivery and sponsor oversight.
• Act as an escalation point for operational risks, issues and vendor performance concerns.
• Partner with Data Management, Statistics and Regulatory colleagues to ensure alignment of study delivery, database lock and reporting timelines.
• Ensure assigned studies remain inspection-ready and support regulatory inspections when required.
• Facilitate onboarding of study team members and external partners.

What You'll Bring

Essential Qualifications & Experience

• Bachelor's degree in Life Sciences, Health Sciences, Technology or a related discipline, or an equivalent combination of education, training and experience.
• 5+ years' experience in the pharmaceutical industry and/or a Clinical Research Organisation (CRO), including 3+ years of clinical study management/oversight experience.
• Significant clinical trial management support experience, such as Clinical Trial Assistant, Clinical Trial Associate or Lead CRA experience.
• Experience supporting either early-phase clinical studies or Phase II/III studies.
• Experience working on global or international clinical studies or programmes.
• Knowledge of global clinical research regulations and compliance requirements, including
  • ICH-GCP
  • US CFR requirements
  • EU Clinical Trial Regulation (CTR)
  • Awareness of local country requirements

Preferred Qualifications

• Experience across multiple therapeutic areas.
• Advanced degree (Master's or Doctorate).
• Additional relevant training, fellowships, internships or similar development experiences.

Key Skills

• Demonstrated success in project and programme management.
• Strong matrix leadership and stakeholder management skills.
• Excellent communication and influencing capabilities.
• Strong organisational, analytical and problem-solving skills.
• Ability to manage competing priorities in a complex global environment.
• Excellent collaboration and teamwork skills.
• Fluent written and spoken English.

Why Join Us?

You’ll have the opportunity to work in a highly collaborative global environment, helping to advance clinical development programmes that have the potential to transform patient outcomes. You’ll partner with experts across multiple functions while developing your own leadership and study management expertise on a global scale.

Compensation Range

zł212,800.00 - zł292,600.00

Locations

Warsaw, Poland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time