Senior Clinical Study Program Manager

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

Job summary

Roche in Santa Clara, CA is seeking a Clinical Study Program Manager to direct multiple exploratory research and clinical projects within PHCS. You will lead cross-functional teams, manage budgets, and ensure on-time, within-scope delivery with high customer satisfaction.

On-site presence is required 3 days/week. Ideal candidates have 8–12 years in clinical trial or project leadership, 5+ years in project management, and strong regulatory/compliance expertise (CLIA/CAP, GCP).

Qualifications

• 8–12 years of experience in clinical trial or project leadership.
• 5+ years in project management and 3+ years managing direct reports.
• Deep understanding of CLIA/CAP regulations and GCP frameworks; regulatory know-how.

Responsibilities

• Develops cross-functional project plans, timelines and budgets to deliver clinical study collaborations on schedule.
• Leads joint project meetings, tracks portfolio performance and resolves risks with scalable solutions.
• Manages a team of clinical study project managers and provides day-to-day guidance.
• Serves as primary contact for Pharma and client partners, delivering status updates and financial reporting.
• Directs protocol execution, IRB submissions and data management with compliance across sites.
• Ensures adherence to quality standards and regulatory inspections.

Skills

Clinical trial leadership

Project management

Autonomy

Regulatory compliance

Lab compliance (CLIA/CAP)

Data tools fluency

Communication & influence

Stakeholder management

Education

Bachelor’s degree in life sciences

Job description

Roche in Santa Clara, CA is seeking a Clinical Study Program Manager to direct multiple exploratory research and clinical projects within PHCS. You will lead cross-functional teams, manage budgets, and ensure on-time, within-scope delivery with high customer satisfaction.

On-site presence is required 3 days/week. Ideal candidates have 8–12 years in clinical trial or project leadership, 5+ years in project management, and strong regulatory/compliance expertise (CLIA/CAP, GCP).