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Job DescriptionAbout the Role
At Takeda, we are united by our purpose of creating better health for people and a brighter future for the world. We are seeking a Lead Clinical Study Manager (Lead CSM) to drive the operational strategy and execution of clinical studies across assigned programmes.
In this role, you will lead cross-functional study teams and partner closely with internal stakeholders and external vendors to ensure delivery of clinical studies that are high quality, compliant, and executed on time and within budget. This is a critical role supporting Takeda’s global clinical development strategy.
Key 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
About You
- Bachelor’s degree (or equivalent) in life sciences or a related field
- 6+ experience in clinical research/pharmaceutical industry, including strong experience in clinical study management (global studies preferred)
- Proven ability to lead cross-functional teams in a matrix environment
- Strong knowledge of global clinical regulations (e.g., ICH-GCP, EU CTR, US CFR)
- Excellent project management, problem-solving, and organisational skills
- Strong communication and stakeholder management capabilities
- Fluent English (written and spoken)
Working at Takeda
We offer a truly collaborative, purpose-driven environment where innovation, integrity, and patient focus are at the heart of everything we do.
This role follows a hybrid working model to support both flexibility and team collaboration.
Diversity, Equity & Inclusion
At Takeda, we are committed to fostering a diverse, equitable, and inclusive environment where every individual can thrive. We believe that diversity of backgrounds, perspectives, and experiences drives innovation and strengthens our ability to deliver for patients.
We welcome applications from all qualified candidates and are dedicated to creating an inclusive workplace where everyone feels valued, respected, and empowered to achieve their full potential.
More About Us
Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to advancing innovative medicines across gastroenterology, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines.
Locations
Warsaw, Poland
Base Salary Range:
zł252,600.00 - zł347,380.00
For information about our benefits, please click here.
LocationsWarsaw, PolandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Skills Required
- Bachelor’s degree or equivalent in life sciences or a related field
- 6+ years of experience in clinical research or the pharmaceutical industry
- Strong experience in clinical study management
- Experience with global clinical studies
- Ability to lead cross-functional teams in a matrix environment
- Knowledge of global clinical regulations, including ICH-GCP, EU CTR, and US CFR
- Project management, problem-solving, and organizational skills
- Strong communication and stakeholder management capabilities
- Fluent written and spoken English
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 — Retirement benefits include a dollar-for-dollar 401(k) match with immediate vesting, plus an additional annual contribution that increases with age and service. These features are positioned as a notable strength in the U.S. offering.
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Parental & Family Support — Family supports span extended paid bonding leave alongside fertility, adoption, surrogacy, childcare, and caregiver resources. The scope of these programs is broad and prominent within the package.
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Healthcare Strength — Health coverage spans PPO and HSA-enabled options with prescription, dental, and vision, complemented by mental-health support and a 24/7 EAP. The breadth of coverage and wellness resources is a recurring highlight.
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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