Clinical Site Manager, Near-Patient CVMD Studies

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La position

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.

We see ourselves and our customers as a team that can only reach its full potential together. By listening closely to patients and physicians, and leveraging digitalisation and new technologies, we get closer to their real-world needs. This collaborative spirit creates an environment where ideas can grow and new ways of doing things can be tried - resulting in competitive products that get to patients faster .

Our work spans the entire product lifecycle, from discovery to post-launch. By collaborating with internal teams, external partners, and patients, the CDMA chapter provides crucial medical insights, designs and executes clinical studies, and offers on-market support. Ultimately, we generate the comprehensive clinical evidence that demonstrates product safety, effectiveness, and scientific validity - facilitating smooth product registration, adoption and reimbursement globally so we can save lives and improve patient quality of life .

As a Clinical Site Manager for the Study Delivery Near Patient Care CVMD team, you are designing, planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical research studies at the clinical study sites. You are delivering other data generation methodologies, working independently to ensure studies are delivered, recorded, and reported in accordance with protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements.

The Opportunity

• Acting 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.

• Performing 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.

• Developing and managing 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.

• Overseeing 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.

• Executing 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.

• Validating product performance claims, supplying data for critical regulatory submissions, defining the functional and clinical utility of products, and gathering feedback and opinions from laboratories or customers regarding the products.

• Working 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.

Who You Are

• You bring a Bachelor's degree in Science Degree preferably in Health Sciences like Clinical Diagnostics or engineering (or equivalent combination of education and work experience)

• You have working experience in either the Medical Device or Diagnostics industry, and working experience in clinical study of IVD/Medical Device/Drug.

• You have experience particularly in the cardiovascular/metabolic indication and Near Patient Care or Point of Care.Experience with studies in an emergency department setting is a plus.

• Excellent understanding of ICH GCP guidelines in the execution of clinical trials

• Exhibits the ability to make sound decisions and to analyze and solve problems; makes independent choices and takes responsibility

• Demonstrates flexibility and adaptability to perform in a fast-paced, matrixed environment where fluid, cross-team collaboration is crucial.

At Roche, you'll thrive in a culture that values different perspectives and creates a place of belonging, where we challenge ourselves to excel and achieve strong results, together. Let's create a healthier, brighter future for all.

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. Qui nous sommes

Un avenir plus sain nous pousse à innover. Ensemble, plus de employés à travers le monde sont dédiés à faire progresser la science et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Nos efforts aboutissent à plus de 26 millions de personnes traitées avec nos médicaments et plus de 30 milliards de tests réalisés avec nos produits de Diagnostique. Nous nous encourageons mutuellement à explorer de nouvelles possibilités, à favoriser la créativité et à conserver nos grandes ambitions, afin de fournir des solutions de santé qui changent des vies et ont un impact mondial.

Construisons ensemble un avenir plus sain.

Roche est un employeur offrant l'équité en matière d'emploi.