Clinical Study Program Manager
About The Position
At Roche, we foster a culture where individuality is embraced, and personal expression, open dialogue, and genuine connections are encouraged. We value, accept, and respect everyone for who they are, enabling personal and professional growth. Our mission is to prevent, stop, and cure diseases and ensure universal access to healthcare for present and future generations. Join Roche, where every voice matters. 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.
Requirements
- Bachelor’s degree in medical technology, chemistry, biology or other life sciences
- 8–12 years of experience managing projects or clinical trials within a regulated CRO, diagnostic, or pharmaceutical environment.
- 5+ years in dedicated project management
- 3+ years managing direct reports, with a proven track record of driving results both independently and cross-functionally.
- Deep understanding of CLIA lab operations, CAP/CLIA regulations, and California Business and Professions Code for high-complexity molecular diagnostics.
- Proficient with project management platforms, data summary tools, and web-based applications.
- Exceptional written, verbal, and presentation skills with a strong ability to manage key stakeholder relationships.
Nice To Haves
- Hands-on experience with Laboratory Developed Tests (LDTs)
- Proficiency in ICH-GCP, GDPR, CAP, and GCP frameworks highly preferred.
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 through dashboards, and proactively resolves complex risks with scalable solutions.
- Manages a team of clinical study project managers, offering clear direction, mentorship, and day-to-day operational guidance.
- Serves as the primary contact for Pharma and client partners, delivering regular status updates, financial reporting, and invoicing management.
- Directs Clinical Study Protocol execution (IRB submissions, financial tracking) and data management systems, ensuring strict adherence across sites.
- Advises teams on GCP, GDP, and CAP/CLIA regulations, conducting routine quality record reviews and study binder audits alongside QA.
- Writes and updates SOPs, sample-management workflows, and reconciliation plans in partnership with lab leadership to solve complex operational challenges.
- Implements best practices and facilitates knowledge exchange between QA, Business Development, Lab Leadership, and external partners.
Benefits
- Relocation benefits are not available for this job posting.
- A discretionary annual bonus may be available based on individual and Company performance.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
