Study Start Up Lead

Descripción del puesto:

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 key member of the Country Study Start-Up Team, you will play a crucial role in delivering clinical trials to patients by driving and facilitating efficient study start-up processes. This position requires enabling innovative clinical trial delivery, addressing study start-up needs across various therapeutic areas, and ensuring seamless trial execution for patients, investigators, and clinical site staff.

The Opportunity:

This role is responsible for the efficient and compliant initiation of Roche-sponsored clinical trials. This involves:
* Creating and executing effective strategies for trial initiation.
* Managing and ensuring timely and efficient site activation and regulatory compliance.
* Identifying and implementing enhancements at both country and site levels, including automation, standardization, and innovation.
* Maintaining consistency with global strategies and timelines.
* Handling all trial amendments throughout the study lifecycle.
* Working with external and internal partners (regional/global counterparts, CROs) to streamline systems and improve timelines.
* Participating in external industry collaborations and engaging with government and institutional bodies (e.g., Ethics Boards, Health Authorities) to align on clinical trial policies and practices.

Who you are:

The person in this role has excellent written and verbal communication, as well as strong interpersonal skills. Posses robust organizational, analytical, and problem-solving abilities. Collaborative and adaptable, with a keen attention to detail, and sense of ownership. Is able to effectively lead through complex and ambiguous situations, particularly within matrixed and global team structures.
* Degree (MD, PhD, MA/MS, BA/BS) in life sciences or equivalent. Postgraduate degree or master's degree is highly preferred.
* Demonstrated expertise in clinical trial start-up, regulatory submissions, and cross-functional collaboration. Strong understanding of ICH-GCP, EU CTR, and relevant local regulatory frameworks. Experience in managing vendor and Contract Research Organization (CRO) relationships.
* Fluency in written and spoken English is required.
* Skilled in using clinical systems such as Veeva Vault, CTIS, and RIM

Relocation benefits are not available for this position

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