Clinical Study Program Manager - Lead Clinical Trials

Biopharma Careers; California (MO); On-site; USD 130,000 - 241,000; Full time

Job summary

Roche in Santa Clara, CA is seeking a Clinical Study Program Manager to lead cross‑functional exploratory clinical studies. You will direct projects from initiation through contract completion within our PHCS division, collaborating with laboratories and support teams to ensure timely, on‑budget delivery and high customer satisfaction.

The role requires strong project management, leadership, and regulatory/compliance experience in CAP/CLIA environments.

Qualifications

• Bachelor’s degree in medical technology, chemistry, biology or other life sciences.
• 8–12 years of experience managing projects or clinical trials within regulated CRO, diagnostic, or pharmaceutical environments.
• 5+ years in dedicated project management and 3+ years managing direct reports.
• Deep understanding of CLIA, CAP/CLIA regulations, and California Business and Professions Code for high‑complexity molecular diagnostics.
• Hands-on experience with LDTs and proficiency in ICH-GCP, GDPR, CAP, and GCP frameworks.

Responsibilities

• Develops cross-functional project plans, timelines, and budgets to deliver clinical study collaborations on schedule and within financial targets.
• Leads joint project meetings, tracks portfolio performance, and resolves complex risks with scalable solutions.
• Manages a team of clinical study project managers, providing direction and mentorship.
• Serves as primary contact for Pharma and client partners, delivering status updates and financial reporting.

Skills

Project management

Leadership

Regulatory compliance

GCP/GDP knowledge

Data tools

Communication

Education

Bachelor's degree in life sciences

Tools

PM platforms

Data summary tools

Job description

Roche in Santa Clara, CA is seeking a Clinical Study Program Manager to lead cross‑functional exploratory clinical studies. You will direct projects from initiation through contract completion within our PHCS division, collaborating with laboratories and support teams to ensure timely, on‑budget delivery and high customer satisfaction.

The role requires strong project management, leadership, and regulatory/compliance experience in CAP/CLIA environments.