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A healthier future. Its 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. Thats 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.
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
Who you are:
You hold a Bachelors (or Masters) degree in computer science life sciences statistics informatics or a related field
You have a minimum of 5-7 years of experience in clinical data management or a related function or an advanced degree with 5-7 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
Preferred Qualifications:
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)
Relocation benefits are not available for this posting
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A healthier future drives us to innovate. Together more than 100000 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.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Manager
F. Hoffmann-La Roche AG is a Swiss multinational healthcare company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange. The company headquarters are located in Basel.