Global Study Lead

Company: Disability Solutions
Location: Pleasanton
Posted on: October 6, 2024

Job 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 PositionA 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 improve effectiveness and efficiency in how we deliver value to patients and customers.The Opportunity:Leads the global study team with full accountability for the study deliverables with respect to quality, budget, and timelines, in collaboration with the Study Team, and ensures the development of high-quality study designs for sponsored studies in collaboration with internal and external experts. In collaboration with Program Leadership, prepares different scenarios for evidence generation (e.g., studies, real-world evidence) in cross-functional collaboration (e.g., with Regulatory Affairs, R&D, CDMA Project Teams) to support global strategies and the planning of timeline and costs. Develops key study documents, including the Design Validation Plan, protocol, study training materials, study forms and templates, and study report. Oversees planning and operational aspects of companion diagnostics studies sponsored by Pharma partners. Additionally, the role is accountable for the study-level budget of assigned studies.

• Adherence to regulations, guidelines and standard operating procedures, and ensures audit/inspection readiness.
• Execution of sponsored studies for assigned areas of focus for registrational and/or non-registrational purposes through all study phases (planning, start-up. conduct and close-out). Overseas 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 maintain 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 maintain 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.Who You Are:
  • 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 clinical trial management knowledge and experience in the oversight and conduct of clinical trials within the core laboratory or serology diagnostics indication areas
  • You have a conceptual and practical knowledge of Product Development and basic knowledge of Clinical Operations or related areas.Preferred Qualifications:
    • You have experience or background in multiple disease areas is a plus.
    • You have clinical trial management knowledge and experience in the oversight and conduct of clinical trials within the Personalized Healthcare Solutions (PHCS)/Companion Diagnostic studies (in partnership with a Pharma partner) area.
    • You have clinical trial management knowledge and experience in the oversight and conduct of clinical trials within the pathology/tissue diagnostics indication areas.
    • Knowledge of best approaches 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 consensusRelocation benefits are not available for this job posting.The expected salary range for this position based on the primary location of Pleasanton, CA is $94,600 and $207,400 annually of hiring range. 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.Who we areAt 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 .

Keywords: Disability Solutions, Lincoln , Global Study Lead, Accounting, Auditing , Pleasanton, California