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A Human Touch: Study Management for Clinical Trials

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Study Managers are critical to the success and cost-effectiveness of your trial. Here’s what to look for when recruiting a Study Manager.

Efficient study management is crucial for the success of any clinical trial.[1] The process of drug development, already exceedingly complex, can hinge on whether the Study Manager has performed their role effectively. [2]

This article addresses the integral role played by clinical trial Study Managers, helps you to understand their value and support their work, and presents some key qualities to look for in the hiring process.

 

1. The complexities of study management

MESM investigates the most crucial areas of study management and how these contribute to the success of a clinical trial.

Financial planning

Study Managers deal with large and complex budgets and managing them is not a one-off task. Timelines are intricate and changeable. The Study Manager’s financial plan must be flexible enough to accommodate these changes.

Third-party liaison

Study Managers make the tough choices when it comes to choosing suppliers and external vendors. These partnerships are critical to the success of a clinical trial. The chosen partners must be able to provide time-sensitive, effective solutions which can adapt to the shifting timeline of a clinical trial. MESM works with Study Managers to ensure an effective and successful equipment management workflow. This will make all the difference when it comes to budgeting and avoiding delays.[3]

Recruitment

Study Managers often take the lead in patient recruitment and managing the security of patient data.[4] This is a sensitive process and must be handled accordingly to avoid trial drop-outs. Patient centricity is key to a successful recruitment strategy – learn more here.

Relationship management

Positive internal relationships can make or break a clinical trial, especially in the case of multi-site trials. The Study Manager ensures effective communication between trial sites and provides solutions which work for all parties.

Be informed

Study Managers are ahead of the game when it comes to clinical trial protocol and developments. Study Managers are the go-to resource for information on advancements in the drug development landscape and possible threats.  

 

2. What to look for in a Study Manager

The Study Manager is a critical hire for your clinical trial.[5] Alongside academic and career qualifications, all Study Managers should possess the following traits:

 

  • Attention to detail: Tasks will pile up so keeping an eye on the finite details is key.
  • Confident communication skills: Facilitating conversations across borders and time zones is no mean feat. Study Managers must be confident and proactive when it comes to holding up relationships and easing the flow of communication.[6]
  • Approachability: The Study Manager is often the first port of call for trial concerns. They should be receptive to colleagues’ needs and concerns.
  • Multi-tasker: A good Study Manager can juggle data security, reporting, and budget forecasting with relationship management, easing communication flows, and keeping on top of recruitment methods. It’s a brilliantly varied workflow which only suits those who are comfortable tackling numerous tasks and deadlines under pressure.[7]

 

3. The human touch

The drug development process requires a tremendous effort from all parties. It must be fully supported internally and by external partners. The Study Manager is the vital link between the two as well as supporting internal relationships and communication between trial sites, patients, and laboratory professionals.[8] The Study Manager is the human touch which is essential to the efficiency and cost-effectiveness of a clinical trial.

 

References:

 

[1] http://www.imperialcrs.com/files/ebooks/Effective_Project_Management_For_Clinical_Trials.pdf

[2] https://cyntegrity.com/7-reasons-clinical-trials-fail/

[3] https://www.future-science.com/doi/10.4155/fso.15.89

[4] https://www.nihr.ac.uk/funding-and-support/documents/funding-for-research-studies/manage-my-study/clinical-trials-manager-generic-job-description.pdf

 

[5] https://www.usfhealthonline.com/resources/career/clinical-research-manager-job-description/

[6] https://forteresearch.com/news/4-essential-skills-ideal-clinical-trial-project-manager/

[7] http://www.appliedclinicaltrialsonline.com/top-3-skills-clinical-trial-project-manager

[8] http://careers.abpi.org.uk/case-studies/Pages/Clinical-Research-Manager.aspx