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Nonclinical Data Associate Iv

2 weeks ago

Bengaluru, India Labcorp Full time

**Essential Job Duties**:
**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%)**
- 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.

**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**:
**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.

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