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Roche is a global healthcare and pharmaceutical company focused on advancing patient care through research and development, digital innovation, and collaboration. With a workforce of more than 101,000 employees, the company brings together expertise across technology, manufacturing, business strategy, and other functions that support healthcare innovation. Roche highlights diversity, equity, and inclusion across its international teams and offers career pathways for experienced professionals, students, and graduates, including opportunities connected to its operations in Germany, Austria, and Switzerland.
Clinical Site Manager, Study Start-Up – German-Speaking, Burgess Hill Onsite
Roche is seeking a Clinical Site Manager to launch diagnostic and medical-device clinical studies in Burgess Hill. The role covers site activation, regulatory submissions, and study documentation with international teams.
Description
- Direct complete study start-up work, from site identification and selection through activation
- Oversee submissions to Ethics Committees and Competent Authorities
- Keep trial records, local agreements, and institutional approvals aligned with regulatory deadlines
- Serve as the main start-up contact and clinical trial specialist for assigned site personnel
- Coordinate required certifications
- Create study materials such as informed consent forms and patient instruction guides
- Work with global, local, and virtual teams to deliver clinical diagnostic solutions
- Collaborate across regions, cultures, and time zones to foster inclusive teams
Requirements
- Degree in a scientific or related discipline, or an equivalent combination of education and experience
- Demonstrated experience in clinical operations or clinical trial coordination
- Practical experience with diagnostic and medical-device trials
- Experience overseeing Ethics Committee and Competent Authority regulatory submissions
- Strong knowledge of In Vitro Diagnostic Medical Device frameworks and Medical Device Regulations
- Understanding of ICH-GCP guidelines
- Excellent written and spoken English communication skills
- Ability to establish trusted relationships and influence cross-functional stakeholders
- Capability to manage relationships with external vendors
- German-language skills are advantageous
Benefits
- Flexible working arrangements
- Equal opportunity employment
- Flexible working requests considered
- Inclusive culture that promotes belonging
- Professional collaboration across varied regions, cultures, and time zones
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