Clinical Study Program Manager

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

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Clinical Study Program Manager - Santa Clara, CA

The Opportunity

The Clinical Study Program Manager will direct multiple moderate to complex exploratory research and clinical projects from study initiation through contract completion in our Personalized Healthcare Solutions (PHCS) division. Studies will be conducted within our Roche Molecular CAP/CLIA laboratory and/or through designated research laboratories and will support the efforts of Pharma Services overall. The role requires solid project management, leadership skills and experience in delivering projects on time, within budget. and with high customer satisfaction. This role collaborates closely with cross-functional teams at leadership and supporting levels, playing a critical part in both the short-term success of the Pharma Services business and the long-term direction of Roche's Molecular Laboratories.

Key Responsibilities

• Project & Strategy Execution: Develops cross-functional project plans, timelines, and budgets to deliver clinical study collaborations on schedule and within financial targets.
• Portfolio & Risk Management: Leads joint project meetings, tracks portfolio performance through dashboards, and proactively resolves complex risks with scalable solutions.
• Team Leadership: Manages a team of clinical study project managers, offering clear direction, mentorship, and day-to-day operational guidance.
• Client & Stakeholder Communication: Serves as the primary contact for Pharma and client partners, delivering regular status updates, financial reporting, and invoicing management.
• Protocol & Data Oversight: Directs Clinical Study Protocol execution (IRB submissions, financial tracking) and data management systems, ensuring strict adherence across sites.
• Regulatory Compliance & Quality: Advises teams on GCP, GDP, and CAP/CLIA regulations, conducting routine quality record reviews and study binder audits alongside QA.
• Process Development: Writes and updates SOPs, sample-management workflows, and reconciliation plans in partnership with lab leadership to solve complex operational challenges.
• Continuous Improvement: Implements best practices and facilitates knowledge exchange between QA, Business Development, Lab Leadership, and external partners.

Who You Are:

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

Preferred Qualifications:

• Clinical Trial & Project Leadership: 8-12 years of experience managing projects or clinical trials within a regulated CRO, diagnostic, or pharmaceutical environment.
• Management & Autonomy: 5+ years in dedicated project management and 3+ years managing direct reports, with a proven track record of driving results both independently and cross-functionally.
• Regulatory & Lab Compliance Expertise: Deep understanding of CLIA lab operations, CAP/CLIA regulations, and California Business and Professions Code for high-complexity molecular diagnostics. Hands-on experience with Laboratory Developed Tests (LDTs) and proficiency in ICH-GCP, GDPR, CAP, and GCP frameworks highly preferred.
• Technical & Data Tool Fluency: Proficient with project management platforms, data summary tools, and web-based applications.
• Communication & Influence: Exceptional written, verbal, and presentation skills with a strong ability to manage key stakeholder relationships.

Location

Santa Clara, CA - This position requires regular on-site presence at the primary location 3 days/week, at minimum.

Relocation benefits are not available for this job posting.

The expected salary range for this position based on the primary location of Santa Clara, CA is $129,600- $240,800. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.

Who we are

A healthier future drives us to innovate. Together, more than 100,000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let's build a healthier future, together.

Roche is an equal opportunity employer.

It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence.

The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.