Clinical Site Manager

Roche; Wien; Vor Ort; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

Roche in Sant Cugat del Vallès seeks a Clinical Site Manager specialising in IVDR and Study Start-Up to design, plan, coordinate, and conduct initiation, monitoring, and completion activities for clinical studies at assigned sites.

You will lead regulatory submissions, ensure compliance with SOPs and global guidelines, and collaborate with cross-functional teams to enable efficient trial startups and site activation.

Qualifikationen

• Minimum 3–5 years of experience in a clinical setting or clinical trial coordination.
• Experience with regulatory submissions and ICH/GCP guidelines is desirable.
• Ability to work across global/local teams and adapt to diverse environments.

Aufgaben

• Lead end-to-end study start-up activities, including site selection and activation.
• Manage Ethics Committee and Competent Authority submissions to meet regulatory requirements.
• Provide CRO oversight and coordinate external partner deliverables and milestones.
• Collaborate with cross-functional teams and train site personnel as needed.

Kenntnisse

Clinical trial coordination

Regulatory awareness

Cross-functional collaboration

Ausbildung

Bachelor's degree in science

Jobbeschreibung

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

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 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.

Who we are

A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an Equal Opportunity Employer.