Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
A healthier future. It’s 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. That’s 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 start-up activities for the assigned studies within the Site Alliance and Activation Sub-Chapter under Site Management, Clinical Operations. The position will require strong stakeholder management working closely with Contracting, Legal, Privacy, 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 start-up
You will execute Site Management activities for sponsored studies for assigned area of focus for registrational and/or non-registrational purposes mostly through study start-up 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 cross-functional team members, relevant internal and external partners, in meeting business goals and ensuring operational excellence.
Good communication and interpersonal skills; Ability to successfully multi-task, Effective problem-solving 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
This may be a remote position.
Who You Are
Bachelor’s 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 Site-related essential documents
Familiarity in engaging with and coordinating third party service providers (CROs, Labs, etc.)
Preferred Qualifications
Experience in leading Sponsor and Site-related essential documents, including the use of CTMS for Site Creation & management, eTMF, Sponsor vs. Site requirements
Experience in clinical trials study start-up 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 cross-functional teams.
Good communication and interpersonal skills; Ability to successfully multitask
Effective problem-solving skills; Strong ability to prioritize and aim for results
Relocation benefits are not available for this job posting.
The expected salary range for this position based on the primary location of Arizona is insert $74,300 - 138,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.
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