Lead Clinical Study Manager (Lead CSM)

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

Job summary

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

You will chair the Study Execution Team, oversee CROs and partners, and provide input into study protocols.

Qualifications

• Bachelor’s degree (or equivalent) in life sciences or a related field.
• 6+ years' experience in clinical research/pharmaceutical industry; strong global study management.
• Proven 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 capabilities.
• Fluent English (written and spoken).

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 (ICH‑GCP and Takeda SOPs).
• Oversee CROs, strategic partners, and third-party vendors for 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 with Finance and Programme Leadership.
• Identify, manage, and mitigate study risks, escalating issues as appropriate.
• Support country and site feasibility and selection processes, aligning with study strategy.
• Ensure studies are inspection-ready; support regulatory inspections when required.
• Mentor and support study management team members and contribute to initiatives.

Skills

Cross-functional leadership

Project management

Stakeholder management

Communication

English fluency

Education

Bachelor’s degree in life sciences or related field

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 (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.

Takeda is an equal opportunity employer.

If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability.

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.

• Base Salary Range: zł252,600.00 - zł347,380.00
• Locations Warsaw, Poland
• Worker Type Employee Worker Sub‑Type Regular Time Type Full time