Clinical Study Program Lead - On-site 3x/Week

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

Job summary

Roche Holding AG in Santa Clara, CA is seeking a Clinical Study Program Manager to lead multiple complex exploratory research and clinical projects from study initiation through contract completion in the PHCS division.

The role requires strong project management, leadership, and collaboration across cross-functional teams to ensure on-time delivery, budget adherence, and high customer satisfaction. On-site presence is expected three days per week.

Qualifications

• Bachelor's degree in medical technology, chemistry, biology or life sciences.
• 8–12 years of experience in clinical trial and project leadership in regulated environments.
• 5+ years in project management and 3+ years managing direct reports.

Responsibilities

• Develops cross-functional project plans, timelines, and budgets for clinical study collaborations.
• Leads joint project meetings and tracks portfolio performance with dashboards.
• Mentors and directs a team of clinical study project managers.
• Serves as primary contact for Pharma and client partners, with regular status updates.
• Oversees Protocol execution (IRB submissions, financial tracking) and data systems.
• Advises teams on GCP, GDP, CAP/CLIA regulations, QA processes.
• Writes and updates SOPs and sample-management workflows with lab leadership.
• Facilitates knowledge exchange between QA, Lab Leadership, and partners.

Skills

Project leadership

Autonomy

Regulatory knowledge

Lab compliance

Data tools

Communication

Education

Bachelor's degree in life sciences

Tools

Project management software

Data summary tools

Web-based applications

Job description

Roche Holding AG in Santa Clara, CA is seeking a Clinical Study Program Manager to lead multiple complex exploratory research and clinical projects from study initiation through contract completion in the PHCS division.

The role requires strong project management, leadership, and collaboration across cross-functional teams to ensure on-time delivery, budget adherence, and high customer satisfaction. On-site presence is expected three days per week.