Global Study Lead

Roche

Global Study Lead overseeing Roche’s sponsored clinical and companion diagnostic studies. Managing study quality, budgets, timelines, regulatory compliance, CROs, and cross-functional teams.

Posted 8/25/2026full-timePleasanton • California • 🇺🇸 United StatesSenior💰 $115,400 - $214,400 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing the full lifecycle of sponsored studies, ensuring compliance with regulatory requirements, and delivering high-quality study designs. Proven ability to lead cross-functional teams, manage budgets, and maintain collaborative relationships with stakeholders and partners.

Highest-signal resume keywords

Clinical Operations ManagementStudy Design DevelopmentProject ManagementRegulatory ComplianceCollaboration with Cross-Functional Teams

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial ManagementBudget ManagementStudy DocumentationEvidence-Generation PlanningDesign Validation PlansProtocol DevelopmentStudy Report PreparationOversight of CRO ActivitiesInvestigator Initiated StudiesPersonalized Healthcare Solutions

Soft Skills

Analytical JudgmentInnovative ThinkingProblem SolvingLeadershipCollaboration

Industry Keywords

Life SciencesClinical TrialsPathology DiagnosticsCompanion DiagnosticsPharma PartnershipsStandard Operating ProceduresAudit ReadinessResearch Collaboration Studies

About the role

Key responsibilities & impact

Ensure studies are designed, planned, executed, monitored, closed out, and documented appropriately within planned timeframe and cost
Ensure sponsor responsibilities are fulfilled and applicable regulatory requirements are met
Plan and execute study timelines and budgets
Assign and ensure delivery of specific tasks to and from study team members
Provide oversight to CROs, consultants, and medical advisors
Lead global study teams with accountability for quality, budget, timelines, and study deliverables
Develop high-quality study designs with internal and external experts
Prepare evidence-generation scenarios with Program Leadership and cross-functional partners to support global strategies and timeline and cost planning
Develop key study documents, including Design Validation Plans, protocols, training materials, study forms and templates, and study reports
Oversee planning and operations for companion diagnostics studies sponsored by Pharma partners
Manage study-level budgets
Ensure adherence to regulations, guidelines, and standard operating procedures, including audit and inspection readiness
Execute sponsored studies through planning, start-up, conduct, and close-out phases
Oversee outsourced study activities, including CRO activities
Oversee Investigator Initiated Studies and Research Collaboration Studies
Ensure study results are published with the Publication Team
Track project performance and ensure projects are completed on time, within scope, and within budget
Build and maintain collaborative relationships with cross-functional leaders, stakeholders, alliance partners, and CROs

Requirements

What you’ll need

Bachelor's degree in Life Sciences or related field
5+ years of experience managing the full lifecycle of sponsored studies
Extensive experience ensuring study results are published in collaboration with the Publication Team
In-depth knowledge and experience in Clinical Operations in product development
Clinical trial management knowledge and experience in oversight and conduct of clinical trials within pathology/tissue diagnostics indication areas
Clinical trial management knowledge and experience in oversight and conduct of Personalized Healthcare Solutions (PHCS)/Companion Diagnostic studies in partnership with a Pharma partner
Experience managing complex projects using analytical judgment and innovative thinking to assess risks and solve difficult problems
Experience building and maintaining collaborative relationships with cross-functional leaders, internal and external stakeholders, alliance partners, Pharma partners, or CROs
Advanced degree in Life Sciences or related field is preferred
Ability to serve as a resource for colleagues with less experience and provide functional guidance
Ability to lead moderate sized projects with manageable risks and resource requirements
Ability to solve complex problems and exercise judgment based on analysis of multiple information sources
Experience with Investigator Initiated Studies is a plus

Benefits

Comp & perks

Benefits detailed at the link provided below
Discretionary annual bonus may be available based on individual and Company performance