Project manager and CRA manager, let’s explain the words!

We find on various job sites or different laboratories or CRO, multiple terms to define the different evolutions of the CRA profession. Are you lost? We will help you see more clearly.

There are actually two different evolutions of the CRA profession, they hide behind many terms not always easy to explain: CRA leader, clinical trial manager, clinical operations manager, CRA manager, clinical team leader, clinical research manager, clinical study manager, global trial leader, global trial manager, clinical oversight lead …

Project management

The CRA lead: CRA lead is simply a Senior CRA who performs his usual monitoring tasks as well as some operational management tasks that have been delegated to him by a CRA coordinator or project manager. These tasks are reduced in general (management of providers, management of treatment delivery, and validation of monitoring reports…). They allow initiating the senior CRA the project management.

It is known as Lead CRA

The CRA coordinator: the CRA coordinator, meanwhile, is no longer practicing monitoring. He will perform the following tasks under the lead of a project manager:

• Organization and monitoring follow-up of the CRA monitor. He will decide on the distribution of the centers and work between the CRAs and ensure that the objectives in terms of monitoring are kept.
• Training of CRAs monitor. He will train on the protocol and the various aspects of the study and ensure that all training is documented.
• Review and validation of monitoring visit reports. He will review the reports prepared by the CRAs and ensure that the right corrective or preventive actions have been planned by the CRAs. He will report to the sponsor all violations to the protocol.
• Selection and management of centralized laboratories, carriers. He will make quote requests in order to choose with the project manager, centralized laboratories and carriers. Then he will coordinate their work.
• Selection of CROs. He will select CROs and track the progress of their work, if applicable.
• Overall management of therapeutic units (TU). He will follow the delivery of TU in the centers.
• Privileged Interlocutor for certain services (Pharmacovigilance, service of manufacturing and delivery treatments). He will coordinate the action of some intervenors of the study.
• Writing procedures specific to the project.
• Follow the budget specific to the monitoring. He will follow the monitoring budget and ensure that the budget is not exceeded. He will inform the project manager in cases of special observation.
• Writing of the monitoring guide (or monitoring plan). He will draft the monitoring guide that explains the different characteristics of the study (communication mode, numbers of monitoring visits, tasks to perform during the various types of visits, deadline related to monitoring, monitoring report template…)
• Writing CRF filling guide (CRF guidelines). He will write the guide on how to complete the CRF.

It is known as clinical trial manager, clinical team leader, clinical monitoring manager, and clinical oversight lead.

The clinical project manager:

He will have the following role:

• Write the study protocol. All clinical project managers do not write protocols. Everything will depend on the type of structures. The drafting of the protocol may be performed by a medical writer.
• Design, plan and monitor of the project implementation. He selects the countries, CROs, objectives, costs and deadlines.
• Direct or matrix management of the project team (CRAs, MD, Stat, Regulatory Affairs, VP, Marketing…)
• Development and management of the overall budget
• Preparation of specifications, contracts
• Validation of the various plans of the study: Data management plan, Monitoring Plan, Statistics plan, Pharmacovigilance Plan, Treatment management plan.

This position is known as clinical project manager, clinical research manager, clinical study manager, global trial leader, global trial manager.

Line management (hierarchical management)

The CRA manager is in charge of:

• Direct Management of CRA Team. It is the administrative management and functional management
• Recruitment of CRAs. He recruits new CRAs and conducts recruitment interviews. He selects future employees.
• Career management. He takes care to promote the evolution of CRAs, wage readjustments. He can also deal with sanctions.
• Performance Management (training, coaching). He ensures that CRAs are well trained in their profession (English, new regulations) and can accompany them on a trip to follow their evolution.
• Planning in resources needs / budget. He manages resources based on the project managers’s demands in staff.

This position is known as Clinical operations manager, CRA manager.

The positions of « project management » are much more common that the ones of « line management ». You should also remember that some positions may include both types of evolution. You now have all the cards to decrypt job advertisements. Good descovering and good luck!

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