Study Start Up Lead

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.

At Roche Pharma Product Development Global Clinical Operations (PDG) we are determined to transform drug development and realize our Pharma Ambition to deliver 20 transformative medicines addressing diseases with the highest societal burden by 2029. Every role here connects to something real: the health and lives of patients.

As a key member of our Country Study Start-Up team you will drive and facilitate the efficient initiation of clinical trials ultimately helping to deliver innovative treatments to patients.

The Opportunity:

• You will lead the country strategy in a disease area for study start-up driving efficiency innovation and collaboration with external stakeholders.

• You will oversee start-up operations to ensure timely and efficient site activation and regulatory compliance.

• You will identify and lead opportunities for process automation standardization and innovation at both the country and site levels.

• You will collaborate with regional and global counterparts to harmonize systems and improve timelines.

• You will oversee the development and management of clinical trial submissions and amendments ensuring regulatory coordination.

• You will provide strategic oversight for all aspects of budgeting and contract management including developing budget strategies and negotiating with internal and external stakeholders.

• You will participate in external industry collaborations to influence the countrys start-up environment.

Who You Are:

• You have a degree (MD PhD MA/MS BA/BS) in life sciences or a related field with 1-3 years of experience in submissions and cross-functional collaboration.

• You have demonstrated experience in clinical trial start-up

• Proven track record in managing site relationships with a customer centric mindset andmanaging complex clinical trials start-up

• You possess a strong understanding of ICH-GCP EU CTR and local regulatory environments.

• You have excellent communication interpersonal and problem-solving skills with a collaborative mindset.

• Fluency in written and spoken English is mandatory

• Ability to manage multiple priorities and work in a fast-paced dynamic environment.

• Ability to travel if needed.

Preferred:

• A postgraduate degree in clinical trials or clinical research is highly desirable.

Relocation Benefits are not available for this job posting.

We use artificial intelligence to screen assess or select applicants for this role.

This posting is for an existing vacancy at Hoffmann-La Roche Ltd.

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.