Global Study Lead

Roche • Pleasanton, CA

4d • Onsite

About The Position

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.

Requirements

• A 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

• An 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
• 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