Chez Roche, vous pouvez être vous-même et être apprécié pour les qualités uniques que vous apportez. Notre culture encourage l'expression personnelle, le dialogue ouvert et les connexions authentiques, où vous êtes valorisé, accepté et respecté pour ce que vous êtes, vous permettant de prospérer tant personnellement que professionnellement. Voici comment nous visons à prévenir, arrêter et guérir les maladies et à garantir à chacun l'accès aux soins de santé aujourd'hui et pour les générations à venir. Rejoignez Roche, où chaque voix compte.

La 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 integral 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-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.

Qui nous sommes

Un avenir plus sain nous pousse à innover. Ensemble, plus de 100 000 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.

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