Sr. Clinical Data Manager, Regeneron Genetics Center

We are seeking an experienced Senior Clinical Data Manager. The principal responsibilities include: 1. to work with and alongside epidemiologists and other researchers at all levels within the Regeneron genetic center to build research quality data sets and reports using different data sources; 2. to oversee and participate in quality improvement efforts to improve administrative and scientific processes within the CDW; 3. work with electronic health data, claims data, clinical trials data and cohort study data with phenomenal attention to detail and thorough documentation by developing data management plans and by quality management plans that will deliver accurate, timely, consistent and quality data.

As a Senior Clinical Research Data Manager, a typical day may include:

• Identify and implement solutions to project data management issues and concerns, including proactive prevention strategies based on metrics and forecasts.
• Serve as the project and client liaison to clinical informatics including management and provision of project specific data management status, cycle time, and productivity metrics.
• Coordinate and participate in the development of the clinical data model and/or database designs and annotate the CRF (eCRF) according to the specifications.
• Review data acquisition conventions and data review guidelines / diagnostic specifications consistent with the clinical data model, statistical analysis plans, and CRF (eCRF) completion / monitoring conventions.
• Coordinate the development and testing of data management system edit / data validation checks (diagnostics) and special listings / procedures used as tools for the data review and discrepancy management activities.
• Interact and collaborate with other project and specialty team members to support the set-up, maintenance, and closure of the data management aspects of the project to ensure consistent, cohesive data handling and quality.
• Be responsible for advanced planning and risk management for projects (issue escalation, resource management).
• Develop objectives for data review.
• Oversee the technical performance of the data review through delivery of quality data, on-time and on-budget.
• Develop and maintain technical data management competencies via participation in internal and external training seminars.
• Training and adherence to project-specific, global, standardized data management process.
• Collaborate with other departments at RGC on areas for process and efficiency improvement and implement solutions on assigned projects.
• Review literature and research technologies/procedures for improving data management practices at Regeneron.
• Perform other data management duties such user acceptance testing, data listing reviews, data trend reporting, timeline confirmation for database lock, etc.
• Critically review and provide feedback on analyses plans, results and summaries to ensure they are accurate and reliable. Identify potential problems and propose remedies or refinements.

THIS ROLE MIGHT BE FOR YOU IF YOU HAVE:

• Outstanding communication skills and an ability to summarize and present dataset summary.
• Ability to work in a highly interactive environment with a diverse team of colleagues
• Ability to summarize and distil results concisely. Excellent oral presentation and writing skills.
• Knowledge of time and cost estimate development and pricing strategies for data management services, EDC vendor selection, ancillary database transfers.
• Ability to manage multiple projects/priorities.

To be considered for this role, you must have a minimum of 5+ years' experience post Masters in CRO, biotechnology, pharmaceutical company or academia performing global clinical development budgets. Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred; Experience with the R environment for statistical computing and with one or more modern programming language (Python, C/C++, Javascript); Knowledge of SAS or Stata

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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