At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. **The Position** CLINICAL STUDY MANAGER At Roche, we believe it’s critical to deliver medical solutions now – even as we develop innovations for the future. We are passionate about transforming patients’ lives and we are fearless in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. Purpose As a Clinical Study Specialist at Roche, you will play an important role in supporting the effective execution of clinical studies and real-world evidence activities. By coordinating operational aspects of local and global studies, ensuring compliance with ICH/GCP and pharmacovigilance standards, and collaborating with cross-functional stakeholders, you will help drive high-quality study delivery in Serbia and Montenegro and contribute to the development of innovative healthcare solutions for patients. Key Responsibilities As a Clinical Study Manager, you will: + Hold end-to-end accountability for the delivery of Global Studies and Managed Secondary Data Use (SDU) RWE activities + Build and lead high-performing study teams, ensuring all members clearly understand their accountabilities, deliverables, and timelines + Supervise study feasibility and site selection processes; Manage the full lifecycle from site activation to clinical closure, including oversight of monitoring tasks and site relationships + Ensure strict adherence to ICH/GCP, GVP, GPP, and local regulations; Maintain "inspection-ready" documentation at all times and lead the resolution of any audit or inspection-related corrective actions (CAPA) + Maintain study tracking systems, TMF (Trial Master File) quality, and risk management activities (RBQM); Develop sponsor capability questionnaires and ensure robust study documentation + Manage study budgets, approve invoices, and resolve variances + Be fully accountable for vendor deliverables, monitoring their performance, training, and resolving systematic issues to ensure quality and compliance + Review and negotiate study agreements, work orders, and supply requirements to ensure cost-effective execution Requirements & Qualifications + You have a university degree in Medical (Medicine, Pharmacy, Dentistry) + You have at least 1 year of clinical research experience + You can prioritize and manage multiple tasks with high flexibility + You bring proven project management skills, effectively navigating multiple systems and stakeholder groups to deliver high-quality results on time + You have strong ability to present clear directions, motivate teams, and influence stakeholders cross-functionally + You are self-motivated and able to work independently with limited supervision + You have strong attention to detail + You write and speak English fluently + You are self-motivated, passionate about the job with developed customer focus and agility skills + You are open-minded, result-oriented and dedicated to make a difference and open to constant development **Should you answer the above challenges and requirements with YES then this is the right position for you!** **Who we are** At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity. We believe in the power of diversity and inclusion and strive to identify and create opportunities that enable all people to bring their unique selves to Roche. Roche is an Equal Opportunity Employer. **Who we are** A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. **Roche is an Equal Opportunity Employer.**