Data Manager / Data Quality Leader Job at Revel IT (South San Francisco)

Job Description

Contract opening for a Data Manager / Data Quality Leader within the USMA Data Management function who 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. Collaborates 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.

Job Responsibility

Ensure the timely completion of data management deliverables and partner with Functional Service Providers (FSPs), DM CROs and other vendors, overseeing and providing technical expertise in the delivery of high quality data
Contribute to functional, cross functional, enterprise-wide or external initiatives that shape our technical landscape, business and healthcare environments
Require 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
DM lead will contribute to the development of new concepts, technologies, and standards. In addition to demonstrating high proficiency with core DM tasks (being able to work independently with minimum oversight/supervision), provides leadership and strategic direction to DM members and adapts strategies to meet changing needs of program objectives
Project Management: Develop risk management strategies and proactively manage timelines to ensure successful oversight and delivery of studies & projects, 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 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 high quality data and compliance with applicable regulations and standards
Provide Data Solutions: Stay current with and adopt emergent data collection, data management, visualization 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 to analysis and filing (if applicable)
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

Requirements

BS or MS 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 environment
Project Management skills
Able to manage multiple requests and priorities
Demonstrated leadership capabilities and decision-making, negotiation, motivation (self and others) and influencing
Experience with data analytics and/or visualization tools and techniques
Demonstrated entrepreneurial mindset and self-direction, ability to mentor others and willingness to learn new techniques
Knowledge of biological principles, display interest and demonstrate scientific curiosity including understanding of data types and their scientific use (clinical, biomarker, WGS, RNA-seq, etc.

Nice to have

Experience in leading DM study teams and maintaining oversight of all start-up, conduct and close-out activities for multiple complex studies, ensuring fit for purpose quality
Experience in leading the collection of clinical trial and/or Real World Data
Good understanding of molecule and disease area strategies, healthcare environment, as well as strong scientific and technical expertise
Extensive technical and or industry experience (for senior and principal roles)
Experience in enterprise level operating systems and familiarity with databases
Fluency in programming languages (SAS, R, Python, SQL, etc)
Some experience with advanced analytics approaches (e.g. machine learning, AI)
Experience with tools related to technologies required to undertake analyses on large data sources with computationally intensive steps (SQL, parallelization, Hadoop, Spark, etc)
Experience producing interactive outputs (e.g. Shiny, Tableau)
Contributor to open source packages, libraries or functions
Experience implementing reproducible research practices like version control and literate programmer
Experience with SDTM implementation and CDISC standards
Experience with standardized technologies such as MedDRA and WHODrug
BSN, RN, RPh, Pharm D, PA or other applicable health professional qualification preferred.

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Data Manager / Data Quality Leader

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