Senior Clinical Study Program Lead

F. Hoffmann-La Roche AG; Santa Clara (CA); On-site; USD 130,000 - 241,000; Full time

Benefits offered by this job

Discretionary bonus

On-site in Santa Clara

Job summary

Roche seeks a Clinical Study Program Manager in Santa Clara, CA to direct multiple exploratory research and clinical projects within the PHCS division. Lead cross-functional teams, ensure on-time delivery within budget and maintain high customer satisfaction across CRO/Pharma collaborations.

The role requires 8–12 years in clinical study leadership, 5+ years in project management and 3+ years managing direct reports, with strong GCP/CAP/CLIA knowledge and regulatory experience.

Qualifications

• Bachelor's degree in medical technology, chemistry, biology or other life sciences.
• 8–12 years of experience managing projects or clinical trials within a regulated CRO, diagnostic, or pharmaceutical environment.
• 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; familiarity with ICH‑GCP, GDPR, CAP and GCP frameworks.
• Proficient with project management platforms, data summary tools, and web-based applications.

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 through dashboards, and resolves complex risks with scalable solutions.
• Manages a team of clinical study project managers, offering direction and day-to-day operational guidance.
• Serves as the primary contact for Pharma and client partners, delivering status updates and financial reporting.
• Directs Clinical Study Protocol execution (IRB submissions, financial tracking) and data management oversight across sites.
• Advises teams on GCP, GDP, and CAP/CLIA regulations, conducting quality reviews and study binder audits with QA.
• Writes and updates SOPs, sample-management workflows, and reconciliation plans with lab leadership.
• Drives continuous improvement through QA, Business Development, Lab Leadership and external partners.

Skills

Clinical Study Leadership

Portfolio & Risk Management

Team Leadership

Client & Stakeholder Communication

GCP & Regulatory Compliance

Data & PM Tools Fluency

Education

Bachelor's degree in life sciences

Tools

Project management software

Data dashboards

Job description

Roche seeks a Clinical Study Program Manager in Santa Clara, CA to direct multiple exploratory research and clinical projects within the PHCS division. Lead cross-functional teams, ensure on-time delivery within budget and maintain high customer satisfaction across CRO/Pharma collaborations.

The role requires 8–12 years in clinical study leadership, 5+ years in project management and 3+ years managing direct reports, with strong GCP/CAP/CLIA knowledge and regulatory experience.