Lead Clinical Study Manager Lodz, Poland Category: Clinical Development

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use.  I further attest that all information I submit in my employment application is true to the best of my knowledge.Job DescriptionAbout the RoleAt 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 ResponsibilitiesLead the operational planning, strategy, and execution of assigned clinical studies or programmesChair 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 standardsProvide operational input into study protocols and related documentation, ensuring feasibility and alignment with programme strategyLead study budget planning and oversight of external spend, working closely with Finance and Programme LeadershipIdentify, manage, and mitigate study risks, ensuring issues are resolved effectively and escalated where appropriateSupport country and site feasibility and selection processes, ensuring alignment with overall study strategyEnsure studies are inspection-ready at all times, supporting regulatory inspections where requiredMentor and support study management team members and contribute to functional initiativesAbout YouBachelor’s degree (or equivalent) in life sciences or a related field6+ experience in clinical research/pharmaceutical industry, including strong experience in clinical study management or oversight - global studies preferredProven ability to lead cross-functional teams in a matrix environmentStrong knowledge of global clinical regulations (e.g., ICH-GCP, EU CTR, US CFR)Excellent project management, problem-solving, and organisational skillsStrong communication and stakeholder management capabilitiesFluent English (written and spoken)Working at TakedaWe 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 & InclusionAt 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 UsTakeda 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.LocationsWarsaw, PolandBase Salary Range:zł252,600.00 - zł347,380.00For information about our benefits, please click here.LocationsWarsaw, PolandWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time