Job Description

Essential Job Duties:

The Nonclinical Data Associate IV learns to be a lead subject matter expert (SME) in the organization on nonclinical data standardization.

Drug Development and Data Standardization (40%)

• Actively participates in various company and industry groups that focus on data standardization
• Assists in communicating with multiple departments within the company (e.g., IT, science, and operations) about the industry trends and upcoming events (e.g., updated or new data standardization models).
• Interacts with clients in various settings, including teleconferences, in-person meetings, at conference and industry consortium events, or site visits to discuss capabilities, customization, and current/future data standardization details.
• In coordination with other SMEs and management, works with stakeholders to strategize development and enhancement of the data standardization service.
• Assists management with assessing and implementing new technology, automation, and/or processes to reduce errors, improve productivity, and/or quality.

Dataset Production (40%)

• Uses software tools to efficiently and accurately complete job duties. Types of software include word processing, spreadsheet, dataset and table generation, collaboration/sharing, and database applications.
• Knows how to prepare datasets for nonclinical studies
• Generating and quality checking dataset files to ensure compliance with regulatory requirements.
• Demonstrating mastery of the dataset production process and software as the SME for various internal, global, and/or industry working groups.
• Works closely with the dataset production team and application administrators to understand issues in generating and completing datasets and participates in the troubleshooting efforts.

Training and Development (15%)

Assists management with developing, implementing, and reviewing training plans for new staff members.

Delivers training and mentoring to new data associate staff members according to established training plans.

Software Validation (5%)

Participates in software testing activities

Completes beta testing and writes and executes test scripts while maintaining documentation in accordance with Systems Life Cycle methodology which complies with General Principles of Software Validation issued by the Food and Drug Administration (FDA).

Identifies and assists in prioritizing enhancement ideas and documenting requirements for the software to create a more efficient process and/or better product.

Consults with SMEs and management to prepare for meetings with software vendors to demonstrate, discuss, and troubleshoot issues, enhancements, workarounds, and influence decisions related to the scope of software releases.

Experience

At least 4 years preferably in the conduct of nonclinical safety assessment studies, but will also consider data/database management experience

Proven record of independent interactions with clients.

Expertise in data standardization in a regulated environment.

Proficiency with office software (e.g., Microsoft Office Word and Excel, Adobe Acrobat)

Attention to detail, time management skills, and organizational skills

Preferred:

Knowledge or experience using programming applications or formulas such as, but not limited to: SAS, R, Python.

Education/Qualifications/Certifications and Licenses

Bachelor's degree or equivalent experience, preferably in one of the following: life sciences, computer science/information systems, statistics, or mathematics.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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