Leading complex activations at a top cancer center

The Challenge

An NCI-designated cancer center ran a large portfolio of clinical trials across specialties: leukemia, gynecologic oncology, infectious disease, behavioral research, and medical physics. Each study had its own sponsor, protocol requirements, and timeline pressures. Many were high-profile protocols tied to institutional priorities or competitive enrollment targets.

The problem was that all of these studies competed for the same internal resources. The same regulatory coordinators, contract specialists, finance teams, and IRB reviewers handled every protocol. Budget negotiations, contract redlines, and regulatory submissions created dependencies that could stall one study while another moved forward. Without strong coordination, the most important trials didn’t necessarily get activated first.

What We Did

We directed end-to-end study activation across the portfolio. That meant managing each study from initial intake through site activation, with full accountability for timelines and deliverables.

Day to day, we coordinated across every group involved in getting a trial open:

• Worked with principal investigators and study teams to gather protocol-specific requirements
• Managed regulatory submissions, including IRB applications, amendments, and continuing reviews
• Tracked budget and contract negotiations between the institution, sponsors, and CROs (contract research organizations)
• Coordinated with nursing, pharmacy, radiology, and lab services on operational readiness
• Identified and escalated blockers before they caused delays

We managed and trained two start-up managers, building their skills in regulatory processes, timeline management, and cross-functional communication. The goal was to create a team that could handle a growing portfolio without sacrificing quality or speed.

For top-priority protocols, we provided executive-level updates to clinical trial leadership. These updates gave decision-makers clear visibility into where each study stood, what was blocking progress, and what resources were needed to stay on track. When priorities shifted or a sponsor pushed for faster enrollment, we adjusted resourcing across the portfolio accordingly.

The Result

Process improvements we introduced reduced friction in the startup workflow. Clearer handoffs between regulatory, contracts, and finance meant fewer studies sat waiting for a single approval while everything else was ready. Activation timelines became shorter and more predictable.

Documentation stayed inspection-ready throughout. Every regulatory submission, contract execution, and budget approval was tracked and filed in a way that could withstand audit at any point. The two start-up managers we trained took on more of the portfolio independently as it grew.

Leadership got what it had been missing: a single view of where every priority protocol stood, who owned the next step, and what would happen if a decision slipped. When a sponsor pushed on a timeline, the answer came with specifics instead of guesses.