The candidate selected for this position will assist efforts within Veterinary Medicine Research and Development (VMRD) to ingest clinical study data into VMRD Data Management systems from external sources and connect it to other data within VMRD. Successful candidates will have both a strong technical background with proven intermediate to advanced data management skill gained through experience, relational database design, processing of flat files into database tables, and database-to-database mapping; as well as strong communication skill in explaining complex data concepts in a straightforward fashion.
Specific responsibilities for this position include:
Following business standards and defined processes, work with study personnel to create Data Management Plans to ensure data can be collected and transferred to the Clinical Data Management System.
Provide study-specific database setup
Program data ingestion and transformation tasks utilizing SAS and/or SQL
Develop data validation checks using SAS and/or SQL programming
Troubleshoot data issues with customers though ad-hoc investigations
Support statistical analysis, reporting, and regulatory submission requirements
Support VMRD Data Management processes by developing automated data ingestion pipelines that can be used across clinical studies.
Communicate effectively with other departmental colleagues, line management, and customers
Qualifications
Minimum Educational Background:
Bachelor's Degree or equivalent experience in related area
Minimum Work Experience/Skills:
Two or more years of experience working with data in a regulated environment
Experience designing databases that correspond to forms used for data collection
Proven ability with SAS and/or a SQL dialect (SQL Server, MySQL, PostgreSQL, SQLite)
Proven ability to lead or work on several simultaneous projects or activities
Excellent written and verbal communication, including the ability to author technical documentation, provide customer support and training
Desirable Education Background:
Degree in the following areas:
Information Management
Computer Science
Bioinformatics
Data Science and/or Data Analytics
Mathematics
Animal Science
Desirable Work Experience/Skills:
Two or more years in Pharmaceutical R&D (Human Health or Animal Health) in a clinical data management specialty
Experience designing databases that correspond to Case Report Forms used in clinical trials
Experience with electronic data capture systems used in clinical trials
Experience developing automated data ingestion pipelines
Experience with general-purpose programming language (e.g., Python, Javascript, VB)
Experience developing data validation checks
Advanced SAS programming knowledge
Broad understanding of Good Clinical Practices (GCP) and Good Laboratory Practices (GLP)
Desirable Other Attributes:
Self-directed - can work with little supervision on most tasks
Goal-oriented, strong desire to achieve and exceed expectations, consistently meets commitments
Excellent organization, prioritization, and time management skills
Can work effectively under pressure
Maintains a strategic outlook
Has desire and ability to anticipate and plan for future change
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