At Roche Diagnostics Solutions (RDS), our mission is clear: to diagnose earlier, develop faster, and personalise treatment because every patient is unique. Our Clinical Development & Medical Affairs (CDMA) team drives innovation to improve healthcare outcomes globally.
Position Overview
As a Clinical Site Manager for Continuous Glucose Monitoring studies in our Study Delivery Near Patient Care CVMD team, you are responsible for designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies at the clinical study sites. You ensure studies are delivered, recorded, and reported in accordance with protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements.
Responsibilities
- Act as the primary contact and clinical trial expert for assigned study site personnel, coordinating training, certification, and providing technical assistance to ensure successful study execution.
- Perform site assessments and qualification visits to support the site selection decision process and site activation activities, including contracting and obtaining IRB/EC/Health Authority approvals in compliance with regulatory requirements.
- Develop and manage key study site documentation such as Study Monitoring Plans, informed consent documents, source documents, patient instruction guides, and case report forms, while contributing technical expertise to review study protocols, data management plans, reports, and manuscripts.
- Oversee CROs for the delivery of site management activities, including training CRO CRAs, escalating issues, and collaborating with international investigators and key customers while mentoring and supporting colleagues to enhance their skills and expertise.
- Execute site management activities for sponsored studies in assigned focus areas across all phases of study (start‑up, conduct, and close‑out) for both registrational and non‑registrational purposes.
- Validate product performance claims, supply data for critical regulatory submissions, define the functional and clinical utility of products, and gather feedback and opinions from laboratories or customers regarding the products.
- Work in local and global study teams, including virtual teams, demonstrating diversity, cultural awareness, and fostering strong, collaborative relationships with cross‑functional team members, internal stakeholders, and external partners to achieve business goals and ensure operational excellence.
Qualifications
- Bachelor’s degree in Science, preferably in Health Sciences such as Clinical Diagnostics or Engineering (or equivalent combination of education and work experience).
- Working experience in the Medical Device or Diagnostics industry, and solid experience in clinical study of IVD/Medical Device/Drug.
- Experience particularly in the Continuous Glucose Monitoring field.
- Excellent understanding of ISO14155:2026, MDR, and ICH GCP guidelines in the execution of clinical trials.
- Ability to make sound decisions, analyze and solve problems, and take responsibility for independent choices.
- Demonstrates flexibility and adaptability to perform in a fast‑paced, matrixed environment where fluid, cross‑team collaboration is crucial.
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Motherwell. 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.
Roche is an Equal Opportunity Employer.
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