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Job DescriptionClinical Study Manager (CSM)Location: Poland Lodz
Function: Global Clinical Development Operations (GCDO)
Organisation: Global Development Organisation (GDO)
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 ResponsibilitiesAs a Clinical Study Manager, you will:
- 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.
- 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
- Experience across multiple therapeutic areas.
- Advanced degree (Master's or Doctorate).
- Additional relevant training, fellowships, internships or similar development experiences.
- 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.
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
LocationsWarsaw, PolandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull timeSkills Required
- Bachelor's degree in Life Sciences, Health Sciences, Technology, or a related discipline, or equivalent education, training, and experience
- 5+ years of experience in the pharmaceutical industry and/or a Clinical Research Organisation
- 3+ years of clinical study management or oversight experience
- Significant clinical trial management support experience, such as Clinical Trial Assistant, Clinical Trial Associate, or Lead CRA experience
- Experience supporting early-phase or Phase II/III clinical 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, EU Clinical Trial Regulation, and local country requirements
- Strong project and programme management skills
- 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
- Experience across multiple therapeutic areas
- Advanced degree such as a Master's or Doctorate
- Additional relevant training, fellowships, internships, or similar development experiences
Takeda Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Takeda and has not been reviewed or approved by Takeda.
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Retirement Support — Employer-funded retirement is described as notably strong, combining a dollar-for-dollar 401(k) match with an additional company contribution that scales with age and service. Access to an employee stock purchase plan further supports long-term wealth building.
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Parental & Family Support — Paid bonding leave for all parents, substantial adoption/surrogacy reimbursement, and robust caregiver resources (backup care and Maven family-forming support) are emphasized as core strengths. These offerings create a comprehensive safety net for a range of family situations.
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Healthcare Strength — Multiple medical plan options (nationwide PPO/HSA and regional HMOs), employer HSA funding, and integrated mental-health and well-being programs signal depth in coverage. Preventive care is covered in-network, and plan choices by state expand access.
Takeda Insights
What We Do
For over 240 years, Takeda’s propensity to evolve has driven the next generation of innovation, and as a future-focused organization, we’re continuing to drive forward with endurance in our steadfast pursuit to achieve the best outcomes for our patients in a rapidly changing world. We have been preparing for this period of value creation by investing in data, digital and technology, and we’re proud of our employees and their commitment to turning groundbreaking ideas into life-changing impacts. Since our founding in Japan, integrity and putting patients first have been at the heart of our identity, and we will emerge ready for our future as one of the most trusted and science-driven digital biopharmaceutical companies. Join a team where your innovation impacts lives. Together, we’ll realize improved outcomes by improving data quality, enhancing launch execution and improving the patient journey. You’ll play a critical role in accelerating data collection and increasing accuracy across all parts of the business. Patients across the globe will benefit from access to treatments afforded by greater opportunities and efficiency in our research and development.
Why Work With Us
We connect to our history and Japanese heritage through everything we do to bring our purpose, values, vision, and imperatives to life. We are committed to bringing better health and a brighter future to patients. Being a part of Takeda means having the opportunity to be a part of something bigger than yourself.
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