- Adherence to regulations, guidelines and standard operating procedures, and ensures audit/inspection readiness.
- Execution of sponsored studies for assigned area of focus for registrational and/or non-registrational purposes through all study phases (planning, start-up. conduct and close-out). Oversees study activities outsourced to a service provider (i.e., CRO).
- Ensure that study results are published in collaboration with the Publication Team.
- Oversees projects to ensure completion on-time, within scope and budget; and tracks project performance to analyze the completion of short and long term goals.
- Build and maintains strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders and other alliance partners, including CROs, in meeting business goals and ensuring operational excellence.
- Build and maintains relationships with international opinion leaders, investigators and key customers, bringing external know-how in-house for the development of new products and innovative study designs.
- This is a remote based role.
- You are established in career with at least 5 years of experience.
- You hold a Bachelor's degree in Life Science and/or relevant expertise in the Healthcare Industry or a related field.
- You have experience or background in multiple disease areas is a plus.
- You have a conceptual and practical knowledge of Product Development and basic knowledge of Clinical Operations or related areas.
- You have knowledge and experience in the oversight and conduct of clinical trials within the pathology/tissue diagnostics indication areas. You have knowledge and experience in the oversight and conduct of clinical trials within the Personalized Healthcare Solutions (PHCS) area.
- Knowledge of best practices and the role of Clinical Operations in product development; is aware of Roche's place in the market and our value proposition to patients and customers.
- Able to serve as a resource for colleagues with less experience and provides functional guidance; can lead moderate sized projects with manageable risks and resource requirements.
- Solves complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information
- Explains difficult or sensitive information; works to build consensus
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Global Study Lead - Tucson, United States - Roche
Description
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.The Position
Who We Are:
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.
Clinical Operations is dedicated to delivering compliant evidence to bring value to patients and customers. We are organized to maximize effectiveness and efficiency in how we deliver value to patients and customers.
The Opportunity:
Who You Are:
Preferred Qualifications:
Relocation benefits are not available for this job posting.
Who we are
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.
