Clinical Study Manager Warsaw, Mazovia Category: Clinical Development

Job description

Clinical Study Manager Warsaw, Mazovia Apply Now Job ID R0192710 Category Clinical Development Subcategory Research & Development Business Unit Research & Development Job Type Full time 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 Description Clinical Study Manager (CSM) Location: Poland Lodz Function: Global Clinical Development Operations (GCDO) Organisation: Global Development Organisation (GDO) About the Role We are seeking an experienced Clinical Study Manager (CSM) to join our Global Clinical Development Operations team. As a key member of the study execution team, you will be accountable for the operational planning, delivery and oversight of clinical studies supporting global clinical development programmes. You will work collaboratively with cross-functional stakeholders and external partners to ensure studies are delivered to the highest quality standards, on schedule and within budget. This role offers the opportunity to lead complex global clinical studies, influence operational strategy, and contribute to the development of innovative medicines that make a meaningful difference for patients worldwide. Key Responsibilities As a Clinical Study Manager, you will: Lead and participate in cross-functional Study Execution Teams (SETs) for assigned clinical studies. Plan, oversee and deliver clinical trials in compliance with ICH-GCP, applicable regulations and company procedures. Provide operational expertise and input into protocol development and study-related documentation. Drive operational feasibility assessments, including evaluation of patient and site burden. Support country and site feasibility activities and contribute therapeutic and operational expertise to study planning. Develop and implement operational strategies, ensuring appropriate risk identification and mitigation plans are in place. Manage study timelines, budgets and external spend throughout the study lifecycle. Oversee Contract Research Organisations (CROs), strategic partners and external vendors, ensuring effective delivery and sponsor oversight. Act as an escalation point for operational risks, issues and vendor performance concerns. Partner with Data Management, Statistics and Regulatory colleagues to ensure alignment of study delivery, database lock and reporting timelines. Ensure assigned studies remain inspection-ready and support regulatory inspections when required. Facilitate onboarding of study team members and external partners. What You'll Bring Essential Qualifications & Experience Bachelor's degree in Life Sciences, Health Sciences, Technology or a related discipline, or an equivalent combination of education, training and experience. 5+ years' experience in the pharmaceutical industry and/or a Clinical Research Organisation (CRO), including 3+ years of clinical study management/oversight experience. Significant clinical trial management support experience, such as Clinical Trial Assistant, Clinical Trial Associate or Lead CRA experience. Experience supporting either early-phase clinical studies or Phase II/III studies. Experience working on global or international clinical studies or programmes. Knowledge of global clinical research regulations and compliance requirements, including: ICH-GCP US CFR requirements EU Clinical Trial Regulation (CTR) Awareness of local country requirements Preferred Qualifications Experience across multiple therapeutic areas. Advanced degree (Master's or Doctorate). Additional relevant training, fellowships, internships or similar development experiences. Key Skills Demonstrated success in project and programme management. Strong matrix leadership and stakeholder management skills. Excellent communication and influencing capabilities. Strong organisational, analytical and problem-solving skills. Ability to manage competing priorities in a complex global environment. Excellent collaboration and teamwork skills. Fluent written and spoken English. Why Join Us? You'll have the opportunity to work in a highly collaborative global environment, helping to advance clinical development programmes that have the potential to transform patient outcomes. You'll partner with experts across multiple functions while developing your own leadership and study management expertise on a global scale. Compensation Range: zł212,800.00 - zł292,600.00 Locations Warsaw, Poland Worker Type Employee Worker Sub-Type Regular Time Type Full time Apply Now Share this job Facebook Xing LinkedIn Email Related content Learn more Frequently Asked Questions Learn more Healthcare for all Learn more How We Partner Learn more Innovators in Science Award Winners Learn more Luck is not a strategy Learn more Takeda Unveils Newly Renovated Cambridge Building Learn more Our Commitment to the Planet Learn more Our Products Learn more Our R&D Pipeline Learn more Patient Story: Rosie Learn more Putting Patients First Learn more Sustainable Value Report 2023 Learn more Takeda Global Headquarters Learn more Informiere dich über Stellenangebote Takedas Produktionsstandort Learn more Takeda in the US Learn more Takeda’s Global CSR Program Learn more The History of Takeda Learn more Values and Corporate Governance Learn more Takeda Manufacturing - 2021 Facilities of the Year Learn more Takeda Acquires Adaptate Therapeutics Learn more BioLife Plasma Services Learn more Biotech Site in Covington, GA Learn more Takeda’s Position on Climate Change Learn more Corporate Responsibility Learn more <li class="js-hub-item hub-content__item showing-by-filter showing-by-load" data-hub-read-time="" data-hub-origin="False" data-hub-title="Diversity, Equity and Inclusion" data-hub-meta-title="" data-hub-meta="" data-hub-url="jobs.takeda.com/" data-hub-isfallbackpage="False" data-hub-order="0" data-hub-link="https://www.takeda.com/corporate-responsibility/sustainable-value-report/people/diversity-equity--inclusion/" data-hub-image="https://tbcdn.talentbrew.com/company/1113/v3_0/img/content/rc_dei.png" data-hub-created-by="TMP created" data-hub-date-updated="02/26/2025 19:36:57" data-hub-date-created="02/26/2025 19:36:57" data-hub-date-ove