- Entry level
- No Education
- Salary to negotiate
- South San Francisco
Data Manager - Data Engineer
South San Francisco
United States of America
Job ID: 201905-114317
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Job Description Summary
As a DATA MANAGER - DATA ENGINEER within our Clinical Data Management (CDM) function you will work within a team of experts in data life-cycle management who acquire and curate data for use in exploratory research, clinical development and evidence generation. You will collaborate with peers within the function and across the organization to identify, design and execute fit for purpose data management solutions, adhering to F.A.I.R. (Findable, Accessible, Interoperable, Reusable) principles. You will ensure the timely completion of data management deliverables and partner with Functional Service Providers (FSPs) and vendors, overseeing and providing technical expertise in the delivery of high quality data. You may also contribute to functional, cross functional, enterprise-wide or external initiatives that shape our technical landscape, business and healthcare environments. You will need strong strategic, collaboration and communication skills, as well as an entrepreneurial mindset, to evolve the way we collect and deliver data and to develop and deliver medicines for our patients.
● Lay the groundwork for our data users to analyze and visualize our clinical data. Manage data sources and databases and launch tools to enable decision making and drive new scientific insights. Develop, maintain, evolve and own systems, tools, scripts and processes that enable the delivery of FAIR data.
● Collaborate with peers within the function and across the organization to identify, design and execute technology and automation enhancements (new or existing) that supports the FAIRification of data.
● Continue to provide technical expertise (Rave, Spotfire, SDTM) to our study teams, both at the FSP and internal teams. Resourced as a technical SME on our work packages for very complex or specialized study builds.
● Provide technical expertise to technical projects and initiatives, adding programming expertise in the delivery of these projects. E.g. Data Capture Hub (DCH), Data Surveillance, Data Flow.
● Support the use of the DCH, providing technical and programming expertise in the delivery of the SDTMv mapping, safety narrative writing and SAE reconciliation reporting processes.
● Provide reports, listings and visualizations to stakeholders, using Spotfire or ‘R’ on an ad-hoc basis and when required, using scientific and technical know-how to understand the user requests to propose and provide the appropriate solution to present this data.
● Contribute to the programming of and ongoing maintenance of Centralised Monitoring and Data Surveillance tools.
● Data Curation tasks on show cases using a variety of tools, ensuring data is made FAIR as per company requirements.
● Contribute to functional, cross functional, enterprise-wide or external initiatives that shape our technical landscape, business and healthcare environments.
● At times you may be asked to provide technical/programming expertise to support RWD studies. e.g. creating validation code to enhance data quality.
● Proactively engage with stakeholders across the business and biometrics to understand their needs and influence their understanding of decisions made on our function.
● Experience in leading the collection of clinical trial and/or Real World Data.
● Good understanding of molecule and disease area strategies, healthcare environments, as well as strong scientific and technical expertise.
● Experience in enterprise level operating systems and familiarity with databases (Relational Database Management System, RDBMS).
● Fluency in programming languages (SAS, R, Python, SQL etc.).
● Contributor to open source packages, libraries or functions.
● Experience implementing reproducible research practices like version control (e.g., using Git, Rmarkdown) and literate programmer.
● Experience with SDTM implementation and CDISC standards.
● Experience with standardized terminologies such as MedDRA and WHODrug
● BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics OR equivalent industry experience.
● Demonstrated strong collaboration and excellent communication skills – both written and oral (proficiency in English required).
● Knowledge of CDISC data standards.
● Knowledge of ICH-GCP and working in regulated environments.
● Project Management skills.
● Able to manage multiple requests and priorities.
● PROJECT MANAGEMENT : Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies, projects and coding responsibilities, including the implementation and adoption of new technologies.
● STAKEHOLDER MANAGEMENT: Proactively engage with stakeholders across the business to understand their needs and influence their understanding of decisions made in our function. Inform stakeholders of status of key deliverables and act on changing milestones.
● VENDOR MANAGEMENT: Partner with relevant functions for external data vendor selection and management. Oversee development of data transfer agreements with vendors ensuring use of standards, fit-for-purpose data models and transfer intervals.
● DATA COLLECTION AND ACQUISITION: Act as experts for data collection, advising teams and stakeholders on best practices and proposing innovative solutions. Ensure a high quality of data and compliance with applicable pharma industry regulations and standards.
● PROVIDE DATA SOLUTIONS: Stay current with and adopt emergent data collection, data management, visualisation and provision tools and applications to ensure fit-for-purpose and impactful approaches. Deliver on solutions as needed.
● DATA QUALITY REVIEW : Use data surveillance tools and strategies to provide aggregate level reviews designed to identify patterns or anomalies in our data to ensure high quality results.
● DATA CURATION: Organization and integration of data collected from various sources. Maintain value of data through application of FAIR (Findable, Accessible, Interoperable, Reusable) principles.
● SUPPORT ANALYSES: Partner with stakeholders to understand their data insight needs and offer Data Management solutions. Demonstrate a strong understanding of the data flow from collection through to analysis and filing.
● FUNCTIONAL EXCELLENCE : Collaborate and contribute to functional/cross-functional initiatives or goals to promote new ways of working, including emerging technologies. Enable broader and more effective use of data to support the business.
● TECHNICAL CONSULTANT : Offer guidance and advice to peers within the function, to key stakeholders and to FSPs, CRO and collaborative groups on technical solutions to ensure high quality data collection and delivery. Deliver on solutions as needed
Who We Are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry
for more than 40 years, using human genetic information to develop novel medicines for serious and
life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious
illnesses. Please take this opportunity to learn about Genentech where we believe that our employees
are our most important asset & are dedicated to remaining a great place to work.
The next step is yours. To apply today, click on the "Apply online" button.
Genentech is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. For more information about equal employment opportunity, visit our Genentech Careers page.
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About the company
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. We are among the world's leading biotech companies, with multiple products on the market and a promising development pipeline.