Strategic Clinical Study Program Lead

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

Benefits offered by this job

Discretionary annual bonus

Job summary

Roche in Santa Clara, CA seeks a Clinical Study Program Manager to lead exploratory research and clinical projects within the PHCS division, coordinating cross-functional teams across labs and CROs to deliver studies on time and within budget.

This on-site role requires strong project management, regulatory knowledge (GCP/CLIA), and leadership skills, with a 3+ days/week on-site commitment and potential discretionary bonus based on performance.

Qualifications

• 8–12 years of clinical trial and project leadership experience.
• 5+ years in dedicated project management and 3+ years managing direct reports.
• Deep understanding of CLIA/CAP/CLIA regulations and lab compliance.
• Experience with ICH-GCP, GDPR, CAP, and GCP frameworks preferred.
• Proficient with project management platforms and data tools.

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.
• Directs protocol execution (IRB submissions, financial tracking) and data management systems.
• Advises teams on regulatory requirements and conducts quality reviews with QA.
• Writes and updates SOPs and workflows in partnership with lab leadership.
• Implements best practices and facilitates knowledge exchange with stakeholders.

Skills

Project leadership

Cross-functional collaboration

Communication skills

Regulatory knowledge

Data tool fluency

Education

Bachelor's degree in medical technology, chemistry, biology or other life sciences

Tools

Project management platforms

Job description

Roche in Santa Clara, CA seeks a Clinical Study Program Manager to lead exploratory research and clinical projects within the PHCS division, coordinating cross-functional teams across labs and CROs to deliver studies on time and within budget.

This on-site role requires strong project management, regulatory knowledge (GCP/CLIA), and leadership skills, with a 3+ days/week on-site commitment and potential discretionary bonus based on performance.