Clinical Site Manager

Description

At Roche, you can be yourself and will be valued for your unique qualities. Our culture fosters personal expression, open dialogue, and genuine connections. Here, you are appreciated, accepted, and respected for who you are—creating an environment where you can grow both personally and professionally. Together, we aim to prevent, stop, and cure diseases and ensure everyone has access to healthcare—today and in the future. Join Roche, where every voice matters. The Position The position As a Clinical Site Manager specialising in IVDR and Study Start\-Up, you will be responsible for designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies at assigned sites. You will work independently to ensure studies are delivered, recorded, and reported in accordance with protocols, standard operating procedures, and global regulatory guidelines. Key Accountabilities The key accountabilities for this position include, but are not limited to: * Lead end\-to\-end study start\-up activities, driving site selection, activation, and qualification assessments to ensure clinical trials launch efficiently and are compliance\-ready. * Manage Ethics Committee (EC) and Competent Authority (CA) submissions, ensuring all trial documentation is available, local contracts, Ethics Committee and Competent Authority approvals meet stringent regulatory requirements. * Provide robust CRO oversight, monitoring external partner deliverables, tracking milestones, and escalation of any issues. * Act as the primary contact and clinical trial expert for assigned study site personnel, for execution of the study \- including training and coordinating certification of study site personnel, and provide technical assistance, as necessary. * Develop critical study documentation, including informed consent documents, patient instruction guides, and key documents for EC/CA submissions. * Collaborate cross\-functionally with global, local, and virtual teams, demonstrating diversity, cultural awareness, and fostering strong, collaborative relationships with cross\-function team members, internal stakeholders, and external partners to achieve business goals and ensure operational excellence. Responsibilities The following are responsibilities for the individuals in this position: * Adhere to regulations, guidelines and standard operating procedures, and ensure ongoing audit/inspection readiness. * Validate product performance claims, supply data for critical regulatory submissions, define the functional and clinical utility of our products, and obtain the opinions and input regarding our products from laboratories or customers. * Work in local and global study teams, including virtual teams and exhibit diversity and cultural awareness. * Build and maintain strong, collaborative relationships with cross\-functional team members. Who you are * Typically has a minimum of 3\-5 years of experience. * Bachelor's Degree in scientific discipline or related field required, or equivalent combination of education and work experience; experience in a clinical laboratory or clinical study coordination is a plus. * Awareness of the Roche organisation and key organisational drivers as well as the relevant processes, customers and products related to own discipline. * Provides informal guidance to new team members. * Solves potentially complex problems by analysing possible solutions using experience, judgement and precedents. * Explains complex information to others in straightforward situations. Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Sant Cugat del Vallès. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process. Who We Are A healthier future drives us to innovate. More than 100,000 employees worldwide work together to advance scientific progress and ensure everyone has access to healthcare—today and for future generations. Through our commitment, over 26 million people are treated with our medicines and more than 30 billion tests are performed using our diagnostic products. We encourage each other to explore new possibilities, foster creativity, and set ambitious goals to deliver life-changing healthcare solutions. Together, we can shape a healthier future. Roche is an equal opportunity employer.