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

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 integral, local, and 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.

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.




- Bachelors Degree in scientific discipline or related field required, or equivalent combination of education and work experience, experience in a clinical laboratory, 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.

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.

📌 Clinical Site Manager (San Cugat del Vallés)
🏢 Roche
📍 San Cugat del Vallés