# Onboarding Checklist > Generate role-customized onboarding checklists for Talosix new hires. Includes GxP training requirements, system access provisioning, 30/60/90 day milestones, and clinical trial domain training. - Skill: `nroze22/onboarding-checklist` (Agent Skill) - Install (CLI): `npx skillmds@latest add nroze22/onboarding-checklist` - Raw SKILL.md: https://api.skillmd.com/api/skills/nroze22/onboarding-checklist/raw - Safety review: pending - Works with: Claude Code, Claude.ai, OpenAI Codex - Category: Coding & Dev Tools - Author: nroze22 (https://skillmd.com/u/nroze22) - Updated: 2026-09-17 - Page: https://skillmd.com/skills/nroze22/onboarding-checklist --- # Onboarding Checklist Skill Generate comprehensive, role-customized onboarding checklists for new Talosix team members. Clinical trial technology companies require onboarding that covers both standard corporate orientation and regulated industry-specific training. ## When to Use - A new hire is starting and needs an onboarding plan - When creating or updating the onboarding template for a role - When reviewing onboarding completeness for compliance audits - When a team member transitions to a new role requiring additional training ## Onboarding Checklist Structure ### Pre-Start (Before Day 1) **IT & Access Setup (Owner: IT/Manager)** - [ ] Laptop/hardware ordered and configured - [ ] Email account created - [ ] Slack/Teams account provisioned - [ ] Calendar access and team meeting invitations sent - [ ] VPN access configured (if applicable) - [ ] Password manager account created - [ ] Welcome email sent with Day 1 logistics **HR & Admin (Owner: HR)** - [ ] Employment paperwork completed - [ ] Benefits enrollment information sent - [ ] Emergency contact information collected - [ ] Background check completed - [ ] NDA and IP assignment executed - [ ] Payroll setup confirmed - [ ] Office badge/access card prepared (if on-site) **Manager Preparation (Owner: Hiring Manager)** - [ ] Onboarding buddy assigned - [ ] First week schedule created - [ ] 30/60/90 day plan drafted - [ ] Introductory meetings scheduled with key stakeholders - [ ] Role-specific training materials prepared ### Week 1: Orientation & Foundation **Day 1** - [ ] Welcome meeting with manager - [ ] Office tour or virtual workspace orientation - [ ] IT setup verification (laptop, email, Slack, VPN) - [ ] HR orientation: benefits, policies, time tracking - [ ] Meet onboarding buddy - [ ] Read company handbook and acknowledge receipt - [ ] Set up development environment (engineering roles) **Days 2-5** - [ ] Company overview: mission, vision, values, strategy - [ ] Product overview: Talosix EDC platform walkthrough - [ ] Team introductions and role orientations - [ ] Review organizational chart and team structure - [ ] Access remaining systems (see System Access section) - [ ] Begin required training modules (see Training section) - [ ] First 1:1 with manager: review 30/60/90 plan ### System Access Provisioning Grant access based on role. All access follows least-privilege principle. **All Roles:** - [ ] Email and calendar - [ ] Slack (appropriate channels) - [ ] HR system (self-service) - [ ] Time tracking system - [ ] Company wiki/knowledge base - [ ] Document management system (controlled documents) **Engineering Roles:** - [ ] GitHub/GitLab (appropriate repositories) - [ ] CI/CD system (Jenkins, GitHub Actions) - [ ] Cloud console (AWS/GCP/Azure) - read access initially - [ ] Monitoring dashboards (Datadog, Grafana) - [ ] Error tracking (Sentry) - [ ] Database access (read-only for non-production initially) - [ ] Development/staging EDC environment - [ ] IDE license (if applicable) **QA/Validation Roles:** - [ ] Test management system (Zephyr, qTest, etc.) - [ ] Validation document repository - [ ] All EDC environments (dev, staging, UAT, production read-only) - [ ] Bug tracking system - [ ] Change control system **Product Roles:** - [ ] Product management tool (Jira, Productboard) - [ ] Analytics platform - [ ] Customer feedback tools - [ ] Design tools (Figma) - [ ] EDC demo environment **Customer-Facing Roles:** - [ ] CRM (Salesforce, HubSpot) - [ ] Support ticketing system (Zendesk, Intercom) - [ ] EDC demo environment - [ ] Customer communication tools - [ ] Knowledge base (internal and customer-facing) ## Required Training ### All Roles: GxP Fundamentals These trainings are **mandatory** for all Talosix employees and must be completed within the first 30 days: - [ ] **GxP Awareness Training** (2 hours) - What is GxP and why it matters - Talosix's role in the clinical trial ecosystem - Employee responsibilities in a regulated company - [ ] **21 CFR Part 11 Overview** (1 hour) - Electronic records and electronic signatures - Audit trail requirements - How these requirements affect our product and processes - [ ] **Data Integrity (ALCOA+ Principles)** (1 hour) - Attributable, Legible, Contemporaneous, Original, Accurate - Plus: Complete, Consistent, Enduring, Available - [ ] **Information Security Awareness** (1 hour) - Data protection for clinical trial data - Password and access management - Incident reporting - [ ] **SOPs and Controlled Documents** (1 hour) - How to find and follow SOPs - Document control process - Training record management ### Engineering-Specific Training - [ ] **GAMP 5 Software Lifecycle** (2 hours) - Software categories and risk-based approach - Development lifecycle for validated systems - Change control and configuration management - [ ] **Secure Development Practices** (2 hours) - OWASP Top 10 for clinical systems - Code review requirements for validated systems - Audit trail implementation standards - [ ] **Talosix Architecture Overview** (2 hours) - System architecture and technology stack - Database schema and data model - Integration points and APIs - [ ] **Development Workflow** (1 hour) - Branching strategy, code review, CI/CD - Testing requirements and standards - Deployment procedures ### QA/Validation-Specific Training - [ ] **Computer System Validation (CSV)** (4 hours) - Validation lifecycle at Talosix - Protocol development (IQ/OQ/PQ) - Traceability matrix management - Deviation and CAPA process - [ ] **Regulatory Standards Deep Dive** (4 hours) - 21 CFR Part 11 detailed requirements - EU Annex 11 - ICH E6(R2) GCP - Applicable FDA guidance documents ### Customer-Facing Training - [ ] **Clinical Trial Fundamentals** (4 hours) - Drug development lifecycle (Phase I-IV) - Clinical trial roles (sponsor, CRO, sites) - Key regulatory concepts - Common clinical trial terminology - [ ] **Talosix Product Certification** (8 hours) - Full product walkthrough with hands-on exercises - Study build and configuration - Common customer workflows - Troubleshooting and support procedures - [ ] **Customer Communication Standards** (2 hours) - Professional communication for regulated industry - Handling sensitive clinical data discussions - Escalation procedures ## Clinical Trial Domain Training ### Recommended for All Roles (Complete within 90 days) - [ ] **Clinical Trial 101** (self-paced, ~4 hours) - What is a clinical trial and why they exist - Phases of drug development - Key stakeholders: sponsors, CROs, sites, IRB/ethics committees - Role of EDC in clinical data collection - [ ] **EDC Industry Overview** (2 hours) - What is Electronic Data Capture - Market landscape and competitors - How Talosix differentiates - Customer journey from RFP to study close - [ ] **Regulatory Landscape** (2 hours) - FDA, EMA, and other regulatory bodies - GCP (Good Clinical Practice) overview - How regulations shape our product requirements ## 30/60/90 Day Milestones ### 30 Days: Learn **All Roles:** - [ ] Complete all mandatory GxP training - [ ] Understand Talosix's product and market position - [ ] Know key team members and stakeholders - [ ] Understand team processes and workflows - [ ] Complete role-specific system access and tool setup - [ ] Shadow experienced team members in key activities - [ ] Manager check-in: confirm alignment on expectations **Engineering:** - [ ] Development environment fully functional - [ ] Completed first code review as reviewer - [ ] Merged first small PR (bug fix or minor improvement) - [ ] Understand the CI/CD pipeline and deployment process **QA/Validation:** - [ ] Review recent validation packages for context - [ ] Execute existing test scripts on a test study - [ ] Understand the change control process end-to-end **Product:** - [ ] Attend customer calls in observer mode - [ ] Review product roadmap and backlog - [ ] Understand prioritization framework **Customer-Facing:** - [ ] Shadow customer calls and training sessions - [ ] Complete product certification - [ ] Review top support ticket categories ### 60 Days: Contribute **All Roles:** - [ ] Contributing independently to team deliverables - [ ] Participating actively in team ceremonies - [ ] Identified first improvement suggestion - [ ] Complete clinical trial domain training - [ ] Manager check-in: assess progress, adjust plan **Engineering:** - [ ] Owning feature work independently - [ ] Participating in design discussions - [ ] On-call rotation training completed **QA/Validation:** - [ ] Writing validation protocols independently - [ ] Managing test execution for a feature - [ ] Providing quality input in sprint planning **Product:** - [ ] Leading customer discovery calls - [ ] Writing requirements and user stories - [ ] Presenting in sprint reviews **Customer-Facing:** - [ ] Handling customer interactions with minimal supervision - [ ] Completing study builds or configurations independently - [ ] Contributing to knowledge base ### 90 Days: Own **All Roles:** - [ ] Fully integrated and productive team member - [ ] All training complete and documented - [ ] Clear understanding of role expectations and growth path - [ ] Manager check-in: formal 90-day review - [ ] Onboarding feedback: what worked, what to improve **Engineering:** - [ ] Owning a component or feature area - [ ] Participating in on-call rotation - [ ] Mentoring or supporting newer team members (if applicable) **QA/Validation:** - [ ] Owning validation for releases independently - [ ] Contributing to SOP and process improvements - [ ] Audit-ready documentation practices **Product:** - [ ] Owning a product area or feature set - [ ] Driving cross-functional alignment - [ ] Customer relationship building **Customer-Facing:** - [ ] Managing customer accounts independently - [ ] Conducting training sessions - [ ] Contributing to process improvements ## Training Documentation All training must be documented for regulatory compliance: - Training record signed by trainee and trainer - Date of completion recorded - Training materials versioned and controlled - Competency assessment results (where applicable) - Records retained per document retention policy ## Output Format Generate the onboarding checklist as a markdown document customized to the specific role. Include all applicable sections with role-specific items highlighted. The checklist should be ready to copy into the project management tool for tracking.