Global Study Lead, SWA Systems and Automation

Roche•Pleasanton, CA

12h•$105,400 - $195,800•Hybrid

About The Position

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 drives us to innovate, continuously advance science, and ensure everyone has access to the healthcare they need today and for generations to come. We want to build a world where we all have more time with the people we love. That’s what makes us Roche. The Global Study Lead is responsible for ensuring that all studies are designed, planned, executed, monitored, closed out and documented in an appropriate manner within the planned timeframe and cost; ensuring that the sponsor responsibilities are fulfilled, while assuring compliance to all applicable regulatory requirements. Responsible for the timeline and budget planning and execution of studies. Assigns and ensures delivery of specific tasks to/from other members of the study team. Provides oversight to outside support including CROs, consultants and/or medical advisors. The Opportunity Key Accountabilities 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. study, real-world evidence) in cross-functional collaboration (e.g. with Regulatory Affairs, R&D, CDMA Project Teams) to support global strategies and planning of timeline and costs Develops key study documents (i.e., Design Validation Plan, protocol, study training materials, study forms and templates, study report) Oversees planning and operational aspects of Investigator Initiated Studies, Testing Access Readiness Program & Early Adopter Programs (TARPs) and Research Collaborations Oversees planning and operational aspects of companion diagnostics studies sponsored by Pharma partners Accountable for study-level budget of assigned studies. Responsibilities 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.

Requirements

Minimum of bachelor's degree in Life Science with at least 5 years of relevant expertise in the Healthcare Industry and/or a related field.
Has conceptual and practical knowledge of Product Development and basic knowledge of Clinical Operations or related areas.
Has 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

Nice To Haves

Experience or background in multiple disease areas is a plus.

Responsibilities

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. study, real-world evidence) in cross-functional collaboration (e.g. with Regulatory Affairs, R&D, CDMA Project Teams) to support global strategies and planning of timeline and costs
Develops key study documents (i.e., Design Validation Plan, protocol, study training materials, study forms and templates, study report)
Oversees planning and operational aspects of Investigator Initiated Studies, Testing Access Readiness Program & Early Adopter Programs (TARPs) and Research Collaborations
Oversees planning and operational aspects of companion diagnostics studies sponsored by Pharma partners
Accountable for 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 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.