Lead Clinical Study Manager

POL - 6999 Takeda SCE; Łódź; Hybrid; PLN 253,000 - 347,000; Full time

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

Job Description

About 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 (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 or oversight - 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

Lodz, Poland

Base Salary Range: zł252,600.00 - zł347,380.00

For information about our benefits, please click here.

Worker Type

Employee

Worker Sub-Type

Regular Time

Full time

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s life - including your own.

Equal Opportunity Employer

Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions: Click here to learn about our commitment to Equal Employment Opportunity (EEO). If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please click here.