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.

Clinical Study Program Manager - Pleasanton, CA

A healthier future. It's 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:

Manages multiple moderately to highly complex exploratory and clinical projects from study initiation through contract completion.
Applies solid project management and leadership skills and experience in delivering projects on time, within budget and with high
customer satisfaction. Maintaining strong and harmonious relationships with partners.

Key Responsibilities:

• Leads multiple moderate to highly complex exploratory research and clinical studies from initiation to contract completion, serving as the primary liaison with Pharma partners.

• Develops and manages detailed project plans, coordinates cross-functional timelines, and ensures on-time, within-budget execution of all Pharma Partnering clinical projects.

• Oversees protocol adherence and compliance activities, including IRB submissions, financial tracking, and management of clinical study protocols in alignment with GCP and regulatory standards.

  Manages clinical trial data processes, including data handling, transfers, audits, and maintenance of electronic and physical study binders for Good Documentation Practices.

• Conducts daily reviews of quality and study-related records, initiates internal audits, identifies nonconformances, and ensures corrective actions to maintain data integrity.

• Facilitates project meetings with internal and external stakeholders, prepares agendas, tracks risks and action items, and ensures transparent, ongoing communication with Pharma and internal teams.

• Proactively identifies project risks, resource constraints, and process gaps; proposes and implements solutions to maintain momentum and align with strategic objectives.

• Mentors clinical project managers, promotes continuous improvement through best practices, and supports cross-functional collaboration, including with Regulatory and QA teams.

Who you are:

Required Qualifications & Experience

• You hold a BS. in Life Sciences or in a related field required

• You have 8-12 years of project and/or clinical trial coordinator/management experience in a regulated, CRO, diagnostic, and/or pharmaceutical industry with regulated documentation.

• You have experience with clinical trial management and bio-sample (clinical testing) management.

• You have experience with projects that require rapid activity/milestone achievement.

• You have proficiency in IRB/Ethics committee and Regulatory oversight processes, as well as Quality and Regulatory processes including GCP ICH Guidelines.

Preferred Qualifications:

• You hold a MS/PhD in Life Science or related preferred

• You have specific Project Management training, or Clinical Research training and/or certification

Travel Requirements: Based on business needs

Relocation benefits are not available for this job posting.

This role is graded between SE7 - SE8, however, the final grade will be evaluated on an individual basis

The expected salary range for this position based on the primary location of Pleasanton, CA is $125,400 - $279,200. 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. This position also qualifies for the benefits detailed at the link provided below.

Benefits

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.

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