Global Study Lead: Drive Global Trials & Impact

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

Job summary

Roche Holding AG in Pleasanton, CA seeks a Global Study Lead to ensure studies are designed, planned, executed and closed on time and within budget, with sponsor responsibilities fulfilled and regulatory compliance assured.

You will lead the global study team, develop evidence-generation scenarios, oversee budgets, and manage CROs and partners, while ensuring publication of results with the Publication Team.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 7+ years managing full lifecycle of sponsored studies.
• Experience publishing study results with Publication Team.
• Clinical Operations knowledge in product development and Roche's market position.
• Experience with PHCS/Companion Diagnostic studies with Pharma partners.

Responsibilities

• Leads global study team with accountability for quality, budget and timelines.
• Prepares scenarios for evidence generation in cross-functional collaboration.
• Develops key study documents (design validation plan, protocol, forms).
• Oversees planning and operations of companion diagnostics studies.
• Accountable for study-level budgets and adherence to regulations.
• Executes sponsored studies across all phases; oversees CRO work.
• Oversees Investigator Initiated Studies and Research Collaboration Studies.
• Ensures study results are published with the Publication Team.
• Maintains relationships with cross-functional leaders and alliance partners.

Skills

Project leadership

Cross-functional collaboration

Clinical operations knowledge

Regulatory compliance awareness

Budget management

Stakeholder management

Risk assessment

Problem solving

Education

Bachelor's degree in Life Sciences or related field

Advanced degree in Life Sciences or related field

Job description

Roche Holding AG in Pleasanton, CA seeks a Global Study Lead to ensure studies are designed, planned, executed and closed on time and within budget, with sponsor responsibilities fulfilled and regulatory compliance assured.

You will lead the global study team, develop evidence-generation scenarios, oversee budgets, and manage CROs and partners, while ensuring publication of results with the Publication Team.