Inside Project Tower

What this team does

Runs the study as a whole: timeline, budget, countries, vendors and people.

Turns the protocol into a plan and keeps everyone on it.

Tells the sponsor the truth about where the study is, even on bad weeks.

A day here

1. 8:30Enrolment report. Two countries are ahead, one has not screened anyone in a month.
2. 10:00Call with the CRA lead. The slow country has a site waiting on a contract, not on patients.
3. 12:00The lab vendor wants a change order for extra kits. You check the budget before you say yes.
4. 14:30Sponsor meeting. You show the plan to recover enrolment, not just the numbers.
5. 17:00Update the risk log and the timeline. Database lock just moved two weeks.

Roles, junior to senior

• Clinical trial assistant
• Clinical trial manager
• Project manager
• Feasibility lead
• Vendor manager
• Program or project director

1. Clinical trial assistantTrackers, the trial master file and meeting notes for the study team.Regulatory and Essential RecordsClinical Systems and Data Workflow
2. Clinical trial managerThe day to day running of the study across sites and countries.Clinical Trial ManagerStudy Conduct and Operational ExecutionQualityCommunication
3. Project managerScope, budget and timeline with the sponsor, and the vendors that deliver it.Clinical Trial ManagerStudy Conduct and Operational ExecutionCommunication
4. Feasibility leadWhich countries and sites can really find the patients, before the study starts.Protocol InterpretationCommunication
5. Vendor managerContracts and delivery for labs, couriers, apps and other outside companies.QualityCommunication
6. Program or project directorSeveral studies, the people who run them and the sponsor relationship.QualityCommunicationStudy Conduct and Operational Execution

Who they talk to every day

• Terminal C
• Data Works
• Central Lab
• Reg House
• Safety Watch
• Company Row

Words you will hear

FPI

First patient in. The day the first patient joins the study.

LPO

Last patient out. The day the last patient finishes.

DBL

Database lock. When the data is frozen so it can be analysed.

TMF

Trial master file. Every document that proves how the study was run.

Change order

A request to change the contract because the work changed.

Feasibility

Checking if sites can find enough patients before you pick them.

RACI

A chart that says who does a task, who signs it off and who is told.

Common moves in and out

Trial managers usually come from CRA work, site management or trial assistant roles.

From here people move to program leadership, sponsor clinical operations or vendor management.