ELN Administrator

ELN Administrator

Direct Hire Full-Time Role

Pay Rate: $28 - $33 per hour

Location: Franklin, IN - Onsite Role

Job Summary:

The ELN Administrator is responsible for the management, creation, maintenance, and continuous improvement of Electronic Lab Notebook (ELN) templates used within a regulated Contract Research Organization (CRO). This role supports scientific and operational teams by translating study protocols, assay methods, and regulatory requirements into standardized, compliant, and user-friendly electronic templates to support our Logistics, Metrology, Chemical Reagent Team, and Bioanalytical groups.

Duties and Responsibilities:

• Design, build, and maintain ELN templates for ligand binding assays, including PK, immunogenicity (ADA), and biomarker workflows.
• Design, build, and maintain ELN templates for Critical Reagent workflows.
• May require the user to translate study protocols, assay methods, and SOPs into structured, standardized ELN formats.
• Ensure templates support accurate, complete, and consistent data capture.
• Maintain version control and lifecycle management of ELN templates.
• Serves as a Subject Matter Expert (SME) for ELN Template generation, qualification, and implementation within a regulatory environment.
• Other duties as assigned. Regulatory Compliance & Data Integrity
• Ensure all ELN templates comply with GLP, GCP, and 21 CFR Part 11 requirements for electronic records and signatures. Other regulations may apply.
• Partner with Quality Assurance (QA) to ensure templates meet audit and inspection readiness standards.
• Incorporate data integrity principles (ALCOA+) into all template designs.
• Support audit preparation and responses related to ELN processes. Cross-Functional Collaboration
• Work closely with various B2S team members to understand workflow requirements.
• Collaborate with IT and ELN system administrators (internally & externally) to implement template functionality and updates. Process Improvement & Standardization
• Identify opportunities to improve template usability, automation, and efficiency.
• Drive standardization across assays, studies, and clients where appropriate.
• Contribute to SOP development and best practices for ELN usage. User Support & Training
• Provide guidance and support to laboratory staff on ELN template usage, training, and deployment.
• Assist in troubleshooting template-related issues.
• Develop training materials and conduct user training sessions as needed. Documentation & Change Management
• Manage template change requests and document all updates in accordance with change control procedures.
• Maintain clear documentation of template specifications and configurations.

Requirements and Qualifications:

• Bachelor's degree in Life Sciences, Chemistry, Biology, or a related field, or equivalent combination of scientific and administrative experience.
• 2-5+ years of experience in a regulated laboratory, CRO, or pharmaceutical environment.
• Experience working with Electronic Lab Notebooks (e.g., IDBS E-Workbook, Benchling, LabWare ELN, or similar. Sapio is preferred.
• Experience in developing Electronic Lab Notebook templates is preferred.
• Familiarity with bioanalytical workflows, preferably ligand binding assays.
• Strong attention to detail with the ability to translate scientific procedures into structured digital templates.
• Proficiency in data structuring, formatting, and workflow logic.
• Experience with document control and versioning systems.
• Basic understanding of assay workflows (ELISA, MSD, etc.) is highly desirable. Regulatory Knowledge
• Understanding of GLP, GCP, and 21 CFR Part 11 requirements.
• Familiarity with data integrity principles (ALCOA+). Preferred Qualifications
• Experience specifically supporting ligand binding assay (LBA) environments (PK, ADA, biomarkers).
• Experience using an Electronic Laboratory Notebook system, generation and versioning of templates, and Exposure to LIMS and other laboratory informatics systems.
• Experience with the validation of computerized systems (CSV) or template validation.
• Prior experience in template automation or workflow optimization.

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