Clinical Site Lead: Cardiovascular Trials & Study Delivery

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.

Die Position

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 3 years of working experience in either the Medical Device or Diagnostics industry, and 2 years of 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
  

Behaviors, competencies, and qualities of the ideal applicant.

• 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.

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.

Wer wir sind

Eine gesündere Zukunft treibt uns zur Innovation an. Mehr als 100.000 Mitarbeiter weltweit arbeiten gemeinsam daran, wissenschaftliche Fortschritte zu erzielen und sicherzustellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und für zukünftige Generationen. Durch unser Engagement werden über 26 Millionen Menschen mit unseren Medikamenten behandelt und mehr als 30 Milliarden Tests mit unseren Diagnostik-Produkten durchgeführt. Wir ermutigen uns gegenseitig, neue Möglichkeiten zu erkunden, Kreativität zu fördern und hohe Ziele zu setzen, um lebensverändernde Gesundheitslösungen zu liefern.

Gemeinsam können wir eine gesündere Zukunft gestalten.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.

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