Clinical Investigator Portal / Life Sciences Tech Project Manager Simulation — Pfizer

The scenario

Pfizer's cardiovascular Phase II program runs a single pivotal trial across 30 investigator sites — academic medical centers where research physicians enroll patients, record visits, and report adverse events. The investigator portal is the digital front door to that work: the place site staff log in to complete electronic case report forms, acknowledge protocol amendments, track site activation status, and raise the safety events that the FDA expects sponsors to catch and report. The current portal is six years old, was built for an earlier study design, and the sites have learned to live with its quirks. Clinical Operations wants it refreshed before the trial's second half: a cleaner interface, a modern Medidata Rave eCRF integration, and adverse-event flagging that is fast and unambiguous. The work is scoped as a $1.5M, 14-week initiative. On paper it is a straightforward web refresh with a vendor integration. In practice, the portal is not the hard part. The investigators are academic physicians with their own systems, their own habits, and no particular desire for a tool leadership decided they needed. The Medical Monitor cares about one thing above all — that a safety signal never gets lost — and he does not fully trust that a rebuild will preserve that. The CRO coordinating the sites is measured on activation speed, not on how well anyone adopts a new screen. And Regulatory Affairs will not let a single line reach production without validation evidence. Your real job is not shipping the portal. It is getting thirty skeptical investigators, a safety-first medical monitor, and a CRO that answers to its own metrics to actually use the new portal the way patient safety requires.

What you'll do as the project manager

• →Deliver the refreshed investigator portal to all 30 trial sites by the Day 27 production go-live with zero loss of adverse-event reporting capability.
• →Integrate Medidata Rave eCRF so that case-report-form data flows without manual re-entry, validated to FDA 21 CFR Part 11 standards.
• →Achieve active investigator-site adoption — at least 24 of 30 sites completing a live visit in the new portal within the go-live window.
• →Preserve and improve adverse-event flagging: a reportable event surfaced to the Medical Monitor within the trial's required timeframe, every time.
• →Complete the refresh within the $1.5M capital budget and the 14-week timeline.

Project management skills you'll build

The challenges you'll navigate

• •Investigator sites are comfortable with the current portal and may resist adopting a tool they did not ask for.
• •The Medidata Rave eCRF integration is the critical technical dependency; vendor slippage cascades into every downstream milestone.
• •A pending Protocol Amendment could change data-capture requirements after the build is underway.
• •Adverse-event flagging is patient-safety-critical and regulator-scrutinized; any gap or delay in the rebuilt workflow is a serious risk.
• •The CRO is measured on site-activation speed, not adoption quality, creating a misalignment with the project's real goal.

Technology & stakeholders

You'll manage 7 stakeholders, including Dr. Helene Marchetti (Sr. Director, Clinical Operations), Warren Ashby (Director, Clinical Systems Delivery), Dr. Nathaniel Brandt (Medical Monitor), and more.

What you'll walk away with

A verified, shareable record of a completed enterprise project — plus the PMO deliverables you produced along the way (charter, project plan, SteerCo deck, closure document). It's real, demonstrable project management experience you can put on your resume and speak to in interviews.

Frequently asked questions

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