Roles and responsibilities

The most common area for life scientists to work in is in a coordinating role where tasks may include a subset of the following activities:

• coordinating with the sites where the trial will take place (‘investigator sites’).
• supporting or leading the design, writing and review of the study protocol, case report forms etc.
• ensuring that all ethical and regulatory aspects are considered, collecting relevant documentation, and preparing registration/approval of the trial.
• coordinating all aspects of the trial – for example, delivery of the medicine, patient recruitment via doctors, and schedule for activities associated with the trial with the clinical staff (nurses, doctors) who complete these (pre-assessments, treatment, follow-up).
• in some roles, answering patient questions.
• monitoring the ongoing trial – ensuring all data for the trial is accurately recorded and patients are tracked; following up on any adverse events.
• preparing for and attending internal meetings/calls to review timelines, milestones, budget; preparing for and attending external meetings/calls with vendors, site liaisons, regulatory authorities etc.
• working closely with other team-member e.g. the biostatisticians analysing the data and medical writers who will prepare the final documentation for regulatory submission/publication.

These coordinating roles may involve work directly at the site of the trial, but there are also opportunities for home or office-based roles that involve coordinating clinical trials across multiple locations.

Additionally, there are other roles focused on the management and analysis of clinical trial data. This area can be particularly interesting for life scientists with quantitative or computational backgrounds. Entry-level roles in the data management area generally involve working in electronic data systems to encapture and track data about each participant in the trial, and resolving queries and issues with the data. More senior roles might involve more strategic input on data strategy, data clean-up and analysis etc, as well as supervising more junior staff. 

Career entry and progression

Entry-level roles include ‘Clinical Research Assistants’ and traineeships. Direct entry to operational roles may be possible particularly at CROs – PhDs often enter as ‘Clinical Research Associate’ (CRA) or ‘Clinical Research Monitors’. Some additional training (e.g. online courses providing an overview of clinical research) will increase your chance of entry into an operational role rather than a traineeship. With experience, you will likely advance to more senior roles such as clinical project manager or clinical research coordinator.

Example job titles:

• Clinical research associate/scientist 
• Clinical investigator/researcher
• Clinical trial/study coordinator/lead/project manager
• Clinical research data specialist
• Clinical data associate
• Clinical data team lead
• Clinical research data analyst
• Biostatistician

Knowledge and skills

 In our careers and skills survey, 7 clinical trial management professionals told us about the competencies they used most often. The most commonly selected competencies were:

• Resilient problem-solving (selected by 86% of the respondents)
• Teamwork (selected by 71%)
• Effective communication (selected by 71%)
• Organization (selected by 57%)
• Developing and focusing on a clear vision (selected by 57%)