Global Study Lead, Clinical Operations & Strategy

Roche; Pleasanton (CA); On-site; USD 130,000 - 241,000; Full time

Job summary

Roche in Pleasanton, CA is seeking a Global Study Lead to design, plan, execute, monitor, and close studies within scope, time, and budget, coordinating sponsor responsibilities and regulatory compliance. The role oversees CROs and external experts, ensuring study deliverables meet quality standards.

You will lead cross-functional teams, develop study documents, manage budgets, and publish results with the Publication Team, while building strong partnerships with internal and external

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• 7+ years of experience managing full lifecycle of sponsored studies.
• Experience publishing study results with Publication Team.
• Knowledge of Clinical Operations in product development.
• Experience in pathology/tissue diagnostics trials.
• Experience with PHCS/Companion Diagnostic studies with Pharma/CRO partners.
• Ability to manage complex projects with analytical thinking and risk assessment.

Responsibilities

• Lead global study team with accountability for quality, budget, and timelines.
• Collaborate with Program Leadership to prepare evidence-generation scenarios.
• Develop key study documents (Design Validation Plan, protocol, templates).
• Oversee planning/operational aspects of companion diagnostics studies.
• Manage study-level budgets for assigned studies.
• Ensure compliance with regulations, SOPs, and audit readiness.
• Oversee sponsored studies from planning to close-out with CROs.
• Oversee Investigator Initiated Studies and Research Collaboration Studies.
• Ensure study results are published with Publication Team.
• Build strong cross-functional relationships with stakeholders and partners.

Skills

Clinical operations

Trial management

Budget planning

Cross-functional collaboration

Analytical thinking

Education

Bachelor's degree in Life Sciences or related field

Advanced degree in Life Sciences or related field

Job description

Roche in Pleasanton, CA is seeking a Global Study Lead to design, plan, execute, monitor, and close studies within scope, time, and budget, coordinating sponsor responsibilities and regulatory compliance. The role oversees CROs and external experts, ensuring study deliverables meet quality standards.

You will lead cross-functional teams, develop study documents, manage budgets, and publish results with the Publication Team, while building strong partnerships with internal and external