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.

Desired Skills and Experience

Electronic Lab Notebooks, ELN Administration, ELN Template Development, ELN Template Generation, ELN Template Qualification, ELN Template Implementation, ELN Template Maintenance, ELN Template Version Control, ELN Lifecycle Management, Sapio, IDBS E-Workbook, Benchling, LabWare ELN, Laboratory Informatics, LIMS, Ligand Binding Assays, LBA, PK Assays, Immunogenicity Assays, ADA, Biomarker Workflows, Critical Reagent Workflows, Bioanalytical Workflows, ELISA, MSD, Study Protocols, Assay Methods, SOPs, GLP, GCP, 21 CFR Part 11, ALCOA , Data Integrity, Electronic Records, Electronic Signatures, Regulatory Compliance, Audit Readiness, Inspection Readiness, Quality Assurance, Document Control, Change Control, Template Validation, Computerized System Validation, CSV, Data Capture, Data Structuring, Workflow Logic, Laboratory Operations, CRO, Pharmaceutical Laboratory, Regulated Laboratory Environment, Process Improvement, Workflow Optimization, Template Automation, SOP Development, User Training, Training Materials, Troubleshooting, Cross-Functional Collaboration

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at www.baysidesolutions.com.