Study Start Up Lead

Job Summary

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 member of the PDG Country Study Start-Up Team your primary focus is to drive and facilitate efficient study start-up processes to contribute to the delivery of clinical trials to patients. You will enable innovative clinical trial delivery address study start up needs across various therapeutic areas and ensure seamless trial execution for patients investigators and clinical site staff. Collaboration with local internal and external country teams global study teams and CROs is essential to this role.

Your responsibilities

Strategic Country Leadership: You will spearhead the national study start-up strategy ensuring all operations align with global timelines while driving local efficiency and innovation.

Operational Excellence & Compliance: Youll oversee the end-to-end start-up lifecyclefrom site activation and regulatory submissions to managing complex amendmentsguaranteeing strict adherence to compliance standards.

Process Innovation & Automation: You will act as a change agent by identifying opportunities for standardization and automation collaborating with global counterparts to harmonize systems and accelerate delivery timelines.

High-Level Regulatory Advocacy: By engaging directly with Health Authorities Ethics Boards and government bodies you will influence clinical trial policies and optimize the local regulatory environment.

Disease Area (DA) & Site Strategy: You will develop the country-level Site Engagement strategy aligning clinical priorities with local market maturity and making data-driven investment decisions regarding Principal Investigators and sites.

Strategic Site Intelligence: During the landscaping and setup phases youll provide expert insights into protocol feasibility and site suitability to ensure rapid recruitment and high-quality study settings.

Relationship Management & Escalation: You will serve as the primary local escalation point for operational challenges and build deep long-term partnerships with diverse site stakeholders including clinic administration and pharmacy leads.

Who you are

• Degree (MD PhD MA/MS BA/BS) in life sciences or equivalent. Postgraduate degree or masters degree highly desirable.

• Demonstrated experience in clinical trial start-up regulatory submissions and cross-functional collaboration.

• Strong understanding of ICH-GCP EU CTR and local regulatory environments.

• Experience managing vendor/CRO relationships.

• Proven leadership or line management experience (for PLs).

Who we are

A healthier future drives us to innovate. Together more than 100000 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.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.

Key Skills

• Administrative Skills
• Facilities Management
• Biotechnology
• Creative Production
• Design And Estimation
• Architecture

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