Clinical Study Program Manager

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 A healthier future. It is what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. 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 writt