Study Start-up Lead — Roche

Full description

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 Study Start Up Lead and member of the PDG Country Study Start Up Team, your main focus is on managing and facilitating efficient trial start processes to help deliver clinical trials to patients. You enable the innovative implementation of clinical trials, cover the needs at the start of the trial across different therapeutic areas and ensure a seamless trial implementation for patients: inside, doctors: inside and the staff at the trial centers. Collaboration with local internal and external country teams, global study teams and contract research institutes (CROs) is essential for this role.

In this position, you report to the Country Study Start Up Lead (or Clinical Operations Country Head) and are responsible for the efficient and compliant launch of Roche clinical trials. In doing so, you develop effective start-up strategies, control operational processes and optimize processes at country and test centre level – always in strict compliance with all regulatory requirements.

The possibility

• Strategic & operational management of the start of studies: You lead the country strategy for the start of studies, create and control comprehensive start-up processes including proactive risk minimization, appointment monitoring and knowledge management in order to ensure timely, efficient center activation and compliance with global schedules.
• Authority & Stakeholder Management: You are engaged in cooperation with external industry partners as well as government and advisory bodies (especially Swissmedic and swissethics) in order to coordinate framework conditions for clinical trials and to actively shape the local environment.
• Informed Consent Form (ICF) Management: You strategically design and monitor the entire informed consent management (creation, submission, archiving) to ensure compliance, company standards and best practices.
• Clinical Submissions & Regulations: You are responsible for submissions for clinical trials as well as changes to the test plan throughout the entire study life cycle, answering regulatory inquiries and keeping your knowledge of country-specific regulations (e.g. Human Research Act HFG/KlinV, Therapeutic Products Act HMG as well as for medical devices/IVDRs) up-to-date.
• Documentation, Compliance & Materials: You control the collection and validation of center documents, manage local service providers (without CROs) and are responsible for translation management for study-relevant materials. If necessary, you will commission your own translations and take over the quality check of all texts – regardless of whether they were created locally or provided by global teams.
• Budgeting & Contract Management: In close cooperation with the FMV team, you create fair market value budgets for the respective studies. You negotiate and implement test centre budgets, contracts, confidentiality (CDAs) and exemption/insurance agreements. If test centers require legal adjustments to the contract text, you coordinate closely with the legal department. You also maintain precise contract data for effective financial planning.
• Payment Monitoring & Process Innovation: Monitor payment processes, escalations, and reconciliation, and actively drive process automation, standardization, and system harmonization initiatives on a regional and global scale.

Who you are

• Training & professional experience: Successfully completed studies (MD, PhD, MA/MS, BA/BS) in human medicine, natural sciences or a comparable qualification (postgraduate/master degree highly desirable) as well as proven experience in start-up clinical studies, in regulatory submissions and in cross-functional cooperation in Switzerland.
• Knowledge of ICH-GCP and the Swiss regulatory framework (Swissmedic, swissethics specifications) as well as practical user knowledge in clinical systems (e.g. Veeva Vault, RIM, BASEC).
• Partner & leadership skills: Experience in managing service provider and CRO relationships.
• Personal strengths: Strong communication and interpersonal skills, strong organizational, analytical and problem-solving capabilities, and a collaborative, adaptable mindset with an eye for detail.
• Languages & Lateral Leadership: Ability to navigate cross-functional teams professionally through complex and global matrix structures, as well as negotiation-proof German and English skills in words and writing. Good knowledge of French and/or Italian is a big plus.

Ready for the next step? We look forward to hearing from you. Apply now to discover this exciting opportunity!

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.

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