Senior TPM Skills Challenge – AI Safety Deployment
THE SCENARIO mpathic has just closed a contract with a Fortune 50 pharmaceutical company to deploy its Observing Agent API — an AI safety monitoring platform that evaluates the quality and safety of AI-assisted clinical trial interactions…
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What You'll Be Doing
THE SCENARIO
mpathic has just closed a contract with a Fortune 50 pharmaceutical company to deploy its Observing Agent API — an AI safety monitoring platform that evaluates the quality and safety of AI-assisted clinical trial interactions in real time.
The deployment spans five clinical trial sites across three countries:
- Two sites in the United States (HIPAA, SOC 2 Type II compliance required)
- One site in the United Kingdom (UK GDPR, NHS data governance standards)
- Two sites in Germany (EU GDPR, Data Protection Impact Assessment required)
The AI system at each site monitors live conversations between clinical coordinators and trial participants — including sensitive discussions about medical eligibility, side effects, and adverse events. Monitoring accuracy directly affects whether safety signals are detected in time. There is no acceptable gap in clinical oversight during the transition from pilot to production.
The program must complete full deployment across all five sites within 90 days of contract execution. You are the Senior TPM. The CTO (Brian) has final technical authority. The CEO (Dr. Grin Lord) is the executive sponsor and is directly engaged with the client's VP of Clinical Operations.
Constraint: mpathic's engineering team is four people. The clinical science team owns annotation protocols and quality thresholds but does not report to engineering. The client's clinical operations team controls site access scheduling and has its own program manager — who has never worked with an AI safety vendor before.
Three days before go-live at the first US site, your engineering lead flags a potential data integration issue: the client's EDC (Electronic Data Capture) system is returning inconsistent participant identifiers across API calls. It may be a configuration issue. It may be a data pipeline bug. The root cause is not yet known.
You own the decision on whether to delay go-live.
CONSTRAINTS
Honor all of the following — strong candidates adapt to them; generic AI output will ignore them.
- Engineering team is four people. Your plan cannot assume unlimited engineering bandwidth for parallel site configuration.
- The clinical science team controls annotation quality thresholds and expert protocols. They are not in your reporting line. Your coordination plan must reflect this.
- The client's clinical operations PM has no prior AI safety vendor experience. Your communication framework must account for this — do not assume they understand mpathic's technical architecture.
- mpathic is HIPAA, SOC 2 Type II, and EU GDPR compliant. Your compliance gates must reflect actual regulatory requirements per jurisdiction — not a generic compliance checklist.
- The go-live decision is yours. The CTO has authority but expects you to bring a recommendation, not a question.
What You'll Accomplish
Build a phased, multi-site deployment plan with jurisdiction-specific compliance gates
Design a stakeholder communication framework for technical and non-technical audiences
Develop an incident response plan with severity tiers calibrated to clinical trial context
Demonstrate critical evaluation of AI-generated output in a regulated environment
Make and defend a go-live delay decision under ambiguous conditions
How Your Work Will Be Scored
What to Submit
Program & Risk Plan
Format: .pdf, .doc, .docx, .rtf, .txt, .md
Phased Deployment Plan
Build a phased deployment plan for this program. Your plan should include:
- Workstreams, milestones, and sequencing logic across all five sites — not treated as identical, parallel deployments
- A critical path that reflects the real dependencies between platform configuration, compliance certification, clinical expert onboarding, and go-live readiness per site
- Site-specific compliance gates: what must be signed off before each jurisdiction can go live?
- A risk register with at least five risks — each with probability, impact rating, owner, and mitigation strategy. Include at least one risk that is not a technical risk.
- Your decision on the go-live delay: hold or proceed? State your reasoning, the conditions for your decision, and what you communicate to the client within the next two hours.
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Written Assessment / README with Sections A, B, and C
Format: .pdf, .doc, .docx, .rtf, .txt, .md
README
Section A — Stakeholder Communication Framework
Design your communication cadence for this program. Cover: (1) how you run internal coordination between engineering, clinical science, and customer success; (2) how you structure client-facing updates for the pharma company's VP of Clinical Operations; and (3) what your escalation protocol looks like — with specific thresholds, not generic descriptions. How do you communicate bad news to a client with no prior AI safety vendor experience?
Section B — Incident Response Plan
Define what constitutes an incident for a live clinical trial monitoring deployment. Create severity tiers (at minimum P0, P1, P2) with specific SLAs, notification chains, and resolution ownership per tier. Address: when does a monitoring accuracy degradation become a regulatory notification requirement? What does post-incident review look like for this client?
Section C — AI Usage Log
Document which parts of your submission you used AI tools for, how you used them, and where you applied your own judgment to evaluate, redirect, or override what the AI produced. Be specific.
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Video Walkthrough
Format: .mp4, .mov, .webm
Record your walkthrough as an MP4 or MOV file and upload it directly on the Provn platform as a separate file. In your video, cover:
- Walk through your go-live delay decision — what was your reasoning and what would change your answer?
- Describe how you would run a status call with the pharma client's VP of Clinical Operations the day after a P1 incident. What do you say and what do you not say yet?
- Mandatory AI question: Walk me through one specific moment where you disagreed with, pushed back on, or redirected what the AI gave you — and what you did instead.
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