Lead Clinical Study Manager (Lead CSM)

Takeda; Województwo mazowieckie; Hybride; PLN 253 000 - 347 000; Plein temps

Résumé du poste

Takeda in Warsaw, Poland is seeking a Lead Clinical Study Manager to drive operational strategy and execution of global clinical studies. You will lead cross-functional study teams and partner with internal stakeholders and external vendors to ensure delivery of high-quality, compliant studies on time and within budget.

This role requires a Bachelor’s degree in life sciences, 6+ years in clinical research, strong leadership in matrix environments, and fluency in English.

Qualifications

• Bachelor's degree in life sciences or related field.
• 6+ years in clinical research/pharma with 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 organisational skills.
• Fluent English, written and spoken.

Responsabilités

• Lead operational planning, strategy and execution of assigned clinical studies.
• Chair the Study Execution Team to meet timelines, budget, and quality.
• Oversee CROs and vendors ensuring performance and compliance.
• Provide input into study protocols and documentation for feasibility.
• Lead study budget planning and external spend oversight.
• Identify, manage and mitigate study risks and ensure escalation.
• Support country/site feasibility and alignment with study strategy.
• Ensure inspections readiness and support regulatory inspections.
• Mentor study management team members and contribute to initiatives.

Connaissances

Cross-functional leadership

Project management

Stakeholder management

Problem-solving

Organizational skills

Fluent English

Formation

Bachelor's degree in life sciences or related field

Description du poste

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.

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

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time