Global Study Lead

Roche•Tucson, AZ

6d•$90,400 - $186,400•Onsite

About The Position

At Roche, we foster a culture where individuals can express themselves authentically, are embraced for their unique qualities, and are valued, accepted, and respected. This environment encourages personal expression, open dialogue, and genuine connections, enabling employees to thrive both personally and professionally. Our mission is to prevent, stop, and cure diseases, ensuring universal access to healthcare for current and future generations. Join Roche, where every voice matters. A healthier future is our driving force for innovation. We are committed to advancing science and ensuring that everyone has access to the healthcare they need, today and for generations to come. Our goal is to create a world where we all have more time with the people we love. This is what defines us at Roche. The Global Study Lead is accountable for the appropriate design, planning, execution, monitoring, closure, and documentation of all studies within the allocated timeframe and budget. This role ensures that sponsor responsibilities are met while maintaining compliance with all applicable regulatory requirements. The Global Study Lead is responsible for the timeline and budget planning and execution of studies, assigning and ensuring the delivery of specific tasks to and from other study team members, and providing oversight to external support, including CROs, consultants, and medical advisors.

Requirements

Bachelor's degree in Life Sciences or related field.
5+ years of experience managing the full lifecycle of sponsored studies, ensuring projects meet performance goals within scope, quality, budget, and timeline.
Extensive experience in ensuring that study results are published in collaboration with the Publication Team.
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.
Clinical trial management knowledge and experience in the oversight and conduct of clinical trials within the pathology/tissue diagnostics indication areas.
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.
Experience managing complex projects by using analytical judgment and innovative thinking to assess risks and solve difficult problems.
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

Advanced degree in Life Sciences or a related field.
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.
Ability to solve complex problems; takes a new perspective on existing solutions; exercises judgment based on the analysis of multiple sources of information.

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).
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.