| name | stakeholder-alignment |
| description | Create stakeholder alignment documents including RACI matrices, decision logs, and communication plans for cross-functional clinical trial feature development. |
| allowed-tools | mcp__claude_ai_Atlassian__searchJiraIssuesUsingJql, mcp__claude_ai_Atlassian__searchConfluenceUsingCql, mcp__claude_ai_Atlassian__createConfluencePage, mcp__claude_ai_Atlassian__getConfluencePage |
| argument-hint | [Initiative or feature name requiring cross-functional alignment] |
Stakeholder Alignment
Create structured alignment documents for cross-functional initiatives at Talosix. Clinical trial EDC features often require coordination across engineering, regulatory, clinical operations, customer success, and commercial teams.
Workflow
- Identify the Initiative: Get the feature/initiative name and scope from the user.
- Map Stakeholders: Identify all involved teams and individuals.
- Generate Documents: Produce the requested alignment artifacts.
- Publish: Offer to create a Confluence page for shared access.
Document Types
1. RACI Matrix
Define Responsible, Accountable, Consulted, Informed for each workstream.
Talosix Standard Stakeholder Roles
- Product Management: Feature definition, prioritization, go-to-market
- Engineering: Design, development, code review, deployment
- QA / Validation: Test planning, IQ/OQ/PQ execution, validation documentation
- Regulatory / Compliance: 21 CFR Part 11 review, audit readiness, SOP updates
- Clinical Operations: Domain expertise, workflow validation, customer requirements
- Customer Success: Customer communication, training, UAT coordination
- Commercial / Sales: Positioning, pricing, competitive messaging
- Security / IT: Infrastructure, access control, penetration testing
- Documentation: User guides, release notes, help center updates
- Executive Sponsor: Budget approval, strategic decisions, escalation path
RACI Template
| Activity | Product | Engineering | QA | Regulatory | Clinical Ops | CS | Commercial |
|---|
| Requirements definition | R/A | C | C | C | C | I | I |
| Technical design | C | R/A | C | I | I | -- | -- |
| Development | I | R/A | I | -- | -- | -- | -- |
| Test planning | C | C | R/A | C | C | -- | -- |
| Validation documentation | C | C | R/A | A | C | -- | -- |
| Regulatory review | I | I | C | R/A | C | -- | -- |
| UAT coordination | C | I | C | -- | C | R/A | -- |
| Customer communication | A | -- | -- | C | C | R | C |
| Training materials | C | -- | -- | -- | C | R/A | I |
| Go-to-market | A | -- | -- | -- | C | C | R |
2. Decision Log
Track key decisions for audit trail and alignment.
| # | Date | Decision | Context/Rationale | Decision Maker | Stakeholders Consulted | Impact | Status |
|---|
| 1 | [Date] | [Decision] | [Why] | [Name/Role] | [Names] | [Impact] | Final/Pending |
Decision Categories for EDC Features
- Regulatory: Compliance approach, validation strategy, audit trail scope
- Technical: Architecture, data model, integration approach
- Product: Scope, phasing, MVP definition, UX approach
- Commercial: Pricing, packaging, customer rollout order
- Operational: Training, support model, documentation
3. Communication Plan
| Audience | Message Focus | Channel | Frequency | Owner | Start Date |
|---|
| Engineering team | Technical progress, blockers | Standup / Slack | Daily | Tech Lead | [Date] |
| Product + Eng leads | Milestone tracking | Weekly sync | Weekly | PM | [Date] |
| Leadership | Status, risks, decisions needed | Executive update | Bi-weekly | PM | [Date] |
| Customer Success | Feature details, timeline, talking points | CS briefing | Monthly | PM + CS Lead | [Date] |
| Customers (beta) | Preview, feedback request | Email + webinar | At milestones | CS | [Date] |
| All customers | Release announcement | Release notes + email | At GA | Marketing | [Date] |
| Regulatory | Compliance review gates | Review meeting | At gates | Regulatory Lead | [Date] |
4. Alignment Meeting Agenda Template
## [Initiative] Alignment Meeting - [Date]
### Attendees
[List with roles]
### Agenda (30 min)
1. (5 min) Status update - what's changed since last meeting
2. (10 min) Open decisions requiring input
3. (10 min) Risks and blockers
4. (5 min) Action items and next steps
### Pre-Read
- [Link to PRD / design doc]
- [Link to Jira board]
- [Link to decision log]
### Decision(s) Needed
- [ ] [Decision 1]: Options A vs B, recommendation
- [ ] [Decision 2]: Go/no-go on [scope item]
5. Stakeholder Map
Categorize stakeholders by influence and interest:
High Influence
|
Manage | Collaborate
Closely | Closely
|
Low Interest -+------------- High Interest
|
Monitor | Keep
| Informed
|
Low Influence
For each stakeholder:
- Name / Role: Who they are
- Quadrant: Collaborate / Manage / Inform / Monitor
- Key Concern: What they care about most (e.g., timeline, compliance, cost, UX)
- Communication Preference: Email, Slack, meeting, async doc review
- Potential Blocker?: Yes/No and mitigation
EDC-Specific Alignment Considerations
- Validation gates: QA and Regulatory must sign off before customer-facing releases
- Customer re-validation: Changes to validated features require customer notification and potential re-validation effort
- Audit trail: All decisions affecting data handling must be documented for regulatory inspections
- Change control: Feature changes after requirements freeze must go through formal change control
- Multi-study impact: Changes can affect active studies; rollout must be coordinated with customer study timelines
