nroze22 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.