Study Start-Up Specialist (SSUS)

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 Study Start-Up Specialist (SSUS) plans and develops strategy for start-up activities, prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents to ensure successful recruitment and delivery of trial milestones.

Your Responsibilities

• Collaborates with Clinical Study Leader and sites to ensure timely delivery of start-up milestones and supports site feasibility assessments.

• Ensures inspection readiness of study and site documentation while maintaining compliance with local regulatory requirements.

• Builds efficient collaborations with site staff, ensuring physicians are trained and prepared for studies.

• Develops and updates training documentation, conducting training as necessary.

• Negotiates site contracts/budgets, ensuring adherence to Fair Market Value (FMV).

• Evaluates site practices for quality and integrity, escalating issues to the Clinical Study Leader as needed.

• Manages site performance by tracking start-up milestones and providing logistical support for clinical trial supplies.

Who you are

• Demonstrated strong leadership by successfully leading multi-functional study teams through all stages of clinical studies.

• Proven strategic and organizational skills with a proactive approach to planning, risk management, and contingency embedding.

• In-depth understanding of ICH/GCP regulations and quality requirements, with effective communication skills for clear instructions and team motivation.

• Excellent problem-solving, negotiation, and conflict resolution abilities, fostering collaboration and stakeholder management across teams.

• Committed to creating a psychologically safe environment that empowers individuals and aligns with Roche's values and leadership principles.

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.