Study Start Up Lead

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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.

Key Responsibilities

This role focuses on the efficient and compliant initiation of Roche-sponsored clinical trials by developing and implementing effective start-up strategies overseeing start-up operations and driving process improvements at the country and site level while maintaining regulatory compliance.

Key responsibilities include:

Leading the country strategy for study start-up driving efficiency innovation and collaboration with external stakeholders.

Overseeing start-up operations and ensuring timely and efficient site activation and regulatory compliance.

Ensuring alignment with global strategies and timelines.

Managing amendments throughout the study lifecycle.

Identifying and driving opportunities for process automation standardization and innovation.

Collaborating with regional and global counterparts to harmonize systems and improve

timelines.

Participating in external industry collaborations to influence country start-up

environments.

Engaging with government and institutional bodies to align on clinical trial policies and

practices (e.g. with Ethics Boards Health Authorities).

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.