Whether you are a leading a project with a team that doesn’t report to you or a research manager leading a team of research coordinators, clinical research associates, biostatisticians, data managers or project managers, you’ve probably been in situations where work was not done as planned or expected.
Deliverables don’t get completed primarily due to (1) lack of clarity on the outcome expected, (2) inadequate amount of time allocated for the project or task or (3) a team member was procrastinating till the last minute.
Lack of clarity on the outcome expected
This situation is far more common that one would think. Project managers (including those that may have certifications behind their name) and senior managers sometime fail to provide clear direction to their team. Assuming the team has the right skills needed for the project, providing clarity on the expected outcome is a must.
Here are some tips on how to give and get clarity:
1. Get input from the people doing the work on your vision for a given task or project. For example, if you want to estimate how long it will take to write the clinical study report, you need to get input on the timeline and intermediate deliverables from medical writer, statistician and other individuals who will perform the activity.
2. Make yourself available to the team for questions, particularly during the early phases of the project. Developing a clinical strategy and ramping up clinical sites is hard work. Many people are involved and it is the leader’s responsibility to make herself available during the early project phases.
3. Respond to emails in 12-24 hours whenever possible. If you are slow on emails, your team will be slow too.
4. When a deliverable impacts more than one individual or team, be sure to get necessary alignment with everyone involved. Bigger the organization the more important this gets. Yes, this can slow you down – so you need to first decide whose input you absolutely need
Ask meaningful questions
Time allocated for the task was inadequate
Estimating how much time will be needed to complete a clinical research task or project can be a daunting exercise. Let’s take trial enrollment as an example. It is best to determine enrollment timeline based on data from literature or prior clinical trial experience. However such data is not always available, especially in the case of first generation medical products where previous trials have not been conducted. Also trial enrollment is highly dependent on the quality of centers, competitive clinical trials, and subject inclusion/ exclusion criteria. Given these variables, we don’t have precise information on how long it will take to enroll in a given clinical trial.
It therefore becomes important to understand the assumptions behind the projected timeline. If the assumptions no longer hold true, update the assumptions and the associated timeline.
A team member was procrastinating till the last minute
I’ve been a victim of procrastination. People usually don’t start working on projects that do not interest them, involve some sort of new learning or there is a fear of unknown.
With emotional intelligence, a leader can assess the project’s progress and identify any parts of the project that are not moving forward as expected. This is easier said than done because people are motivated by different things. Simply having an open, non-confrontational, one-on-one conversation with the individual can quickly resolve the situation.
The fear of unknown is a common problem with clinical trial managers. When a new clinical strategy is developed, people don’t know if the strategy will be accepted by the regulatory agency. Once the strategy is accepted, site start-up and enrollment can be slow due to external factors such as site contracts and competing clinical trials. We don’t know if a database lock will happen on or before schedule because this is highly dependent on the site and the patient returning for their follow-up visit. Lastly, after years of work, the medical product may not have the necessary safety and efficacy data needed to secure product approval.
Do you have any other reasons on why a clinical research project can be behind schedule? If so, please share in the comments section below.