Starting a career as clinical trial agreement negotiator is a very important decision. Joining clinical trial industry means becoming a part of a complex and multi-level mechanism that is ultimately designed for one purpose – to make the World healthier. Being new to clinical trials may seem scary, but it is actually not. Step by step, a professional becomes a great project assistant, coordinator, monitor, start-up specialist, lead or project manager etc.

Starting the career, negotiator deals with tons of the new information, and there are some topics one should learn:

• Overview of the clinical trial field.

Good Clinical Practice (ICH-GCP and its local adaptations) is the core regulation for any professional working in the clinical trials industry. Knowledge of GCP is a key element of understanding of how clinical trials work globally. It is not enough just read it once – GCP training shall be periodically refreshed.

• Acronyms.

Dozens if not hundreds or thousands of acronyms are used in daily life of the negotiator. CTA, IRB, EC, EDC, ICF, PA, PV, FPI, AE, SAE… not to mention endless list of abbreviations related to medical procedures. Most of them are defined in the Good Clinical Practice and relevant trial protocol, but there should be no hesitation for the negotiator to consult the manager or more experienced colleague about what is hidden behind this set of letters.

• Clinical Trial Agreement (CTA) and Budget templates.

Knowledge of the local specific regulatory environment is a key to understanding of CTA/Budget templates set-up. Depending on the country where the clinical trial is conducted, the format and content of the CTA/Budget template varies, in some countries the templates are defined by the law and allow very limited amount of edits, other countries may have site- or regional-level obligatory templates, a number of countries accept core sponsors’ templates.

• Negotiation process.

This is another topic that requires local expertise, and timelines for negotiation and templates creation can be quite tough, especially when final templates or even fully executed CTAs are required for regulatory or ethics submission. Reasonable and well-thought negotiation strategy allows to avoid situations when CTA becomes a bottleneck for the whole clinical trial start-up process.

• Team work.

Experienced teammates support the new negotiator at all stages of adaptation to the new professional field. It may seem that working with CTAs is a kind of routine and a bit administrative activity, however it is not the case. Negotiating CTAs is quite complex, creative and often challenging job. At CTA Focus we encourage our newcomers not to hesitate asking questions (as we say, ‘there is only one question that can be treated as a silly question – it is one that was never asked’), we provide full support and guidance. Our style of work and workplace practices proved to be great soil to grow best-in-class professionals.