Global Study Lead

Roche • Pleasanton, CA

5d • $115,400 - $214,400 • Onsite

About The Position

At Roche, we foster a culture where you can show up as yourself, embraced for your unique qualities. 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.

A healthier future is 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.

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. This role is responsible for the timeline and budget planning and execution of studies. It assigns and ensures the delivery of specific tasks to/from other members of the study team and provides oversight to outside support including CROs, consultants, and/or medical advisors.

Requirements

• You have a bachelor's degree in Life Sciences or related field.
• You have 5+ years of experience managing the full lifecycle of sponsored studies, ensuring projects meet performance goals within scope, quality, budget, and timeline.
• You have extensive experience in ensuring that study results are published in collaboration with the Publication Team.
• You have in-depth knowledge and experience in the role of Clinical Operations in product development and are aware of Roche’s place in the market and our value proposition to patients and customers.
• You have clinical trial management knowledge and experience in the oversight and conduct of clinical trials within the pathology/tissue diagnostics indication areas.
• 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 experience managing complex projects by using analytical judgment and innovative thinking to assess risks and solve difficult problems.
• You have prior experience building and maintaining strong, collaborative relationships with cross-functional leaders, key internal and external stakeholders, and other alliance partners, including Pharma partners or CROs, in meeting business goals and ensuring operational excellence.

Nice To Haves

• You have an advanced degree in Life Sciences or a related field.
• You are able to serve as a resource for colleagues with less experience and provide functional guidance; can lead moderate-sized projects with manageable risks and resource requirements.
• You have the ability to solve complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information.
• Experience with Investigator Initiated Studies 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 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 areas 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).
• Oversees planning and operational aspects of Investigator Initiated Studies and Research Collaboration Studies.
• 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.

Benefits

• Relocation benefits are not being offered for this role.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior