Global Study Lead, Clinical Operations

Biopharma Careers; United States; On-site; USD 115,000 - 214,000; Full time

Job summary

Roche seeks a Global Study Lead to drive study design, planning, execution and closure within set timelines and budget. You will coordinate with CROs, medical advisors, and internal teams to ensure compliant, high-quality studies and responsible sponsor governance.

The role emphasizes leadership of study teams, budget oversight, and collaboration across Regulatory Affairs, R&D, and CDMA Project Teams to support global strategies and cost planning.

Qualifications

• Requires 5+ years of experience managing the full lifecycle of sponsored studies.
• Experience publishing study results with the Publication Team.
• Knowledge of Clinical Operations in product development.
• Experience with Investigator Initiated Studies is a plus.

Responsibilities

• Leads the global study team with accountability for quality, budget and timelines.
• Prepares scenarios for evidence generation in cross-functional collaboration.
• Develops key study documents such as Design Validation Plan and protocol.
• Oversees planning and operational aspects of companion diagnostics studies.
• Ensures study-level budget accountability and audit readiness.

Skills

Study management

Budget planning

Cross-functional collaboration

Regulatory compliance

CRO oversight

Publication coordination

Education

Bachelor's degree in Life Sciences

Advanced Life Sciences degree

Job description

Roche seeks a Global Study Lead to drive study design, planning, execution and closure within set timelines and budget. You will coordinate with CROs, medical advisors, and internal teams to ensure compliant, high-quality studies and responsible sponsor governance.

The role emphasizes leadership of study teams, budget oversight, and collaboration across Regulatory Affairs, R&D, and CDMA Project Teams to support global strategies and cost planning.