Senior Data Manager (Clinical Data Management)

RocheSouth San Francisco, CA
1d

About The Position

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. That’s what makes us Roche. This role is based in Data Management, a core function within Product Development Data Sciences (PDD). We lead the industry in speed and efficiency across all data management responsibilities. We achieve this through the development of tools, automation, and the adoption of cutting-edge technologies that streamline clinical trial data collection and delivery. As trusted partners in end-to-end drug development, Data Management leverages deep expertise in cross-therapeutic area data modalities to lead and influence clinical trial data strategy across Roche. We balance the need for high-quality outputs with fit-for-purpose data collection, enabling faster, more efficient trials that support timely decision-making and accelerate the delivery of new medicines to patients. The Opportunity The Data Manager (DM) plays a critical role in ensuring the quality, integrity, and availability of clinical trial data to support decision-making in early and late-stage drug development. Working closely with Biostatistics, Analytical Data Science, and cross-functional partners, the Data Manager leads the design, implementation, and oversight of data management activities across one or more studies. This includes database setup, data cleaning, query resolution, and vendor oversight, with a strong emphasis on regulatory compliance, efficiency, and data readiness for analysis. The role requires both technical acumen and collaborative leadership to anticipate challenges, drive process improvements, and enable high-quality data delivery across the clinical portfolio.

Requirements

  • You hold a Bachelor’s (or Master’s) degree in computer science, life sciences, statistics, informatics, or a related field
  • You have a minimum of 5 years of experience in clinical data management or a related function, or an advanced degree with 3 years of equivalent work experience
  • You have hands-on experience managing data for clinical trials (e.g., CRF design, query resolution)
  • You have working knowledge of EDC systems and data standards (e.g., CDISC)
  • You have a solid understanding of clinical data types and how they relate to analysis
  • You are able to work independently and prioritize across multiple deliverables
  • You are familiar with risk-based monitoring or data quality metrics
  • You demonstrate respect for cultural differences when interacting with colleagues in the global workplace

Nice To Haves

  • Programming literacy (e.g., SAS, R, Python) for data review or visualization
  • Experience with early-phase data types or adaptive study designs
  • Strong interpersonal and communication skills to coordinate with cross-functional partners
  • Exposure to data flow across the clinical systems landscape (e.g., EDC to SDTM)

Responsibilities

  • You independently manage end-to-end data management activities for one or more studies, from CRF and database design to final study closure
  • You collaborate with cross-functional partners (Biostats, Data Science, Clinical) to define data specifications and ensure data meets study needs
  • You collaborate with Clinical Operations to ensure optimal selection of data-related vendors and drive site performance in data entry timeliness and query resolution
  • You resolve complex data issues using industry best practices, knowledge of risk-based monitoring, and system capabilities (e.g., EDC, ePRO, IRT)
  • You evaluate and refine study-level data processes, incorporating feedback and innovations to improve efficiency and data quality
  • You support oversight of third-party vendors to ensure data deliverables meet regulatory and quality expectations
  • You share technical expertise with colleagues and contribute to continuous improvement of team practices and documentation
  • You demonstrate a good understanding of the clinical data ecosystem, proactively identifying data issues, taking ownership of non-CRF data, and knowing where to go to resolve problems efficiently
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