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

A healthier future. Its what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. Thats what makes us Roche.

As Site Management we are the interface between Roche Diagnostics Study Teams and the external clinical study sites/Roche Customers performing the studies. Through a collaborative and strong study site relationship we ensure study/site compliance with applicable regulations and guidelines; affirming the integrity of the generated data and preserving the safety of patients. It is with this expertise and mindset that Site Management facilitates successful clinical trials which are essential to bringing Roche products to market. You will be responsible for site startup activities for the assigned studies within the Site Alliance and Activation SubChapter under Site Management Clinical Operations. The position will require strong stakeholder management working closely with Contracting Study Teams and Sites.

The Opportunity

• You will adhere to regulations guidelines and standard operating procedures and ensure ongoing audit/inspection readiness.

• Deliver high quality and timely global study startup

• You will execute Site Management activities for sponsored studies for assigned area of focus for registrational and/or nonregistrational purposes mostly through study startup phase.

• You will work in local and global study teams including virtual teams and exhibit diversity and cultural awareness.

• Build and maintain strong collaborative relationships with crossfunctional team members relevant internal and external partners in meeting business goals and ensuring operational excellence.

• Good communication and interpersonal skills; Ability to successfully multitask Effective problemsolving skills; Strong ability to prioritize and aim for results.

• Understanding of global regulatory IRB and ethics committee submissions and support and/or coordinate submissions when needed

• Knowledge and understanding of ICH/GCP and global regulatory guidelines/directives

Who You Are

• Bachelors degree in chemistry biology other life sciences or a related field. Experience or background in IVD industry or similar positions

• Knowledge and understanding of ICH/GCP and global regulatory guidelines/directives/IVDR is a plus

• Experience in leading Sponsor and Siterelated essential documents

• Familiarity in engaging with and coordinating third party service providers (CROs Labs etc.

Preferred Qualifications

• Experience in leading Sponsor and Siterelated essential documents including the use of CTMS for Site Creation & management eTMF Sponsor vs. Site requirements

• Experience in clinical trials study startup a plus

• Experience in clinical trial preparation including IRB/Ethics Committee ICFs and contracts

• Strong analytical skills and attention to detail; handling ambiguity; in addition to great organization skills

• Participate and work effectively on multiple crossfunctional teams.

• Good communication and interpersonal skills; Ability to successfully multitask

• Effective problemsolving skills; Strong ability to prioritize and aim for results

Relocation benefits are not available for this job posting.

This role involves no more than 30 travel.

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 lifechanging healthcare solutions that make a global impact.

Lets build a healthier future together.

Roche is an Equal Opportunity Employer.