onboarding-checklist

name	onboarding-checklist
description	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.

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.