Clinical Site Manager (Study Start Up for NPC - German Speaking)

Roche; Wien; Vor Ort; EUR 70.000 - 95.000; Vollzeit

Zusammenfassung

Roche seeks a Clinical Site Manager specializing in Study Start-Up to design, plan, coordinate and conduct activities at assigned sites, ensuring studies are delivered per protocols and regulatory guidelines.

You will lead end-to-end start-up activities, manage EC/CA submissions, coordinate certifications, and develop essential study documents. Collaborate across global teams and foster inclusive environments; German is a plus.

Qualifikationen

• Degree in a scientific discipline or related field with clinical operations experience.
• Hands-on experience managing EC/CA submissions for diagnostic trials.
• Strong knowledge of IVD/MDR and global GxP standards.
• Excellent English communication; German language a plus.

Aufgaben

• Lead end-to-end study start-up activities at assigned sites.
• Manage EC and CA submissions and regulatory timelines.
• Serve as primary contact for start-up activities and site personnel.
• Develop critical study documentation (informed consent, patient guides).
• Collaborate with global, local, and virtual teams to deliver diagnostics.
• Promote inclusive, diverse team environments.

Ausbildung

Degree in a scientific discipline

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

The Opportunity

As a Clinical Site Manager specialising in 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.

In this role, you will:

• Lead end-to-end study start-up activities , driving site identification, selection, and activation to ensure clinical trials launch efficiently and are compliance-ready.
• Manage Ethics Committee (EC) and Competent Authority (CA) submissions, ensuring all trial documentation, local contracts, and institutional approvals meet stringent regulatory timelines.
• Act as the primary contact and clinical trial expert for start-up activities for assigned study site personnel, and coordinate necessary certifications.
• Develop critical study documentation , including informed consent documents, patient instruction guides, etc
• Collaborate cross-functionally with global, local, and virtual teams to help deliver top-tier clinical diagnostic solutions.
• Foster a culture of belonging by partnering across diverse regions, cultures, and time zones to build inclusive team environments.

Who You Are

You are a proactive, collaborative, and highly organised clinical research professional who thrives in a fast-paced, matrixed environment. You possess strong problem-solving skills, make sound independent decisions, and excel at managing external vendor relationships.

To be successful in this role, you bring:

• Education & Experience : A degree in a scientific discipline or related field (or equivalent combination of education and experience) combined with a proven track record in clinical operations or clinical trial coordination.
• Study Start-Up & Submission Expertise : Hands-on experience navigating diagnostic and medical device trials, specifically managing Ethics Committee (EC) and Competent Authority (CA) regulatory submissions.
• IVD/MDR Knowledge : Strong understanding of In Vitro Diagnostic Medical Device frameworks and Medical Device Regulations alongside global standards such as ICH-GCP guidelines.
• Stakeholder Engagement : Exceptional verbal and written communication skills (English) with a proven ability to build trusted relationships and influence cross-functional partners.
• German speaking is a plus.

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 Burgess Hill. 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.

The statements herein are intended to describe the general nature and level of work being performed by employees, and are not to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. Furthermore, they do not establish a contract for employment and are subject to change at the discretion of Roche Products Ltd. At Roche Products we believe diversity drives innovation and we are committed to building a diverse and flexible working environment. All qualified applicants will receive consideration for employment without regard to race, religion or belief, sex, gender reassignment, sexual orientation, marriage and civil partnership, pregnancy and maternity, disability or age. We recognise the importance of flexible working and will review all applicants’ requests with care. At Roche difference is valued and we are proud to be an equal opportunity employer where you are encouraged to bring your whole self to work.