Lead Clinical Study Manager

13 октября 2026 г.

Гибрид

Lead

Warsaw, Poland

Стоит учесть

Английский обязателен

Описание

Lead Clinical Study Manager to drive operational strategy and execution of clinical studies across assigned programmes at Takeda, a global biopharmaceutical company. The role leads cross-functional study teams and partners with internal stakeholders and external vendors to deliver high-quality, compliant studies on time and within budget, supporting Takeda's global clinical development strategy. Based in Warsaw, Poland, following a hybrid working model as a full-time employee.

Обязанности

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

Требования

Bachelor's degree or equivalent in life sciences or a related field
6+ years of experience in clinical research or 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 such as 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

Условия

Hybrid working model to support flexibility and team collaboration
Full-time employee position

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Lead Clinical Study Manager

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