Global Study Lead — Drive End-to-End Clinical Studies

F. Hoffmann-La Roche AG; Pleasanton, Northern (CA, KY); Hybrid; USD 130,000 - 241,000; Full time

Job summary

F. Hoffmann-La Roche AG in Pleasanton, CA is seeking a Global Study Lead to drive the end-to-end design, execution, and documentation of sponsored studies.

You will lead the global study team, develop robust study designs, and manage budgets and timelines in collaboration with internal and external experts. The role requires 7+ years of sponsor study management, clinical trial familiarity in pathology/tissue diagnostics, and a strong track record in cross-functional collaboration with

Qualifications

• Bachelor's degree in Life Sciences or related field required.
• 7+ years of full lifecycle management of sponsored studies.
• Experience in clinical trial management in pathology/tissue diagnostics and PHCS/Companion Diagnostics areas.

Responsibilities

• Lead global study team with accountability for quality, budget, and timelines.
• Develop study designs and key documents (protocol, design validation plan, study report).
• Oversee sponsor study budgets and CRO/outsourcing activities.
• Publish study results in collaboration with the Publication Team.
• Build strong cross-functional relationships with internal/external stakeholders and alliance partners.

Skills

Project management

Budget planning

Clinical operations

Regulatory compliance

CRO oversight

Publication coordination

Stakeholder collaboration

Education

Bachelor's degree in Life Sciences

Advanced degree in Life Sciences (preferred)

Job description

F. Hoffmann-La Roche AG in Pleasanton, CA is seeking a Global Study Lead to drive the end-to-end design, execution, and documentation of sponsored studies.

You will lead the global study team, develop robust study designs, and manage budgets and timelines in collaboration with internal and external experts. The role requires 7+ years of sponsor study management, clinical trial familiarity in pathology/tissue diagnostics, and a strong track record in cross-functional collaboration with