How to Apply For a Clinical Trial Manager Job

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By Sarah Wilson CCRP
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Clinical Trial Manager Job

Clinical Trial Managers are people who help senior management oversee the clinical research project. Read on to find out who typically hire clinical trial managers.

Difficulty: Moderate

Instructions

Things You'll Need:

Proof of education, training and experience related to Clinical Research.
Current Resume

Step 1

Sponsors hire Clinical Trial Managers.

Sponsors of clinical trials are probably the largest employer of Clinical Trial Managers. Sponsors include Clinical Research Organizations or CROs, pharmaceutical companies, device manufacturers, scientists/investigators and any other person holding the IND (Investigational New Drug Application) or NDA (New Drug Application) or other applicable regulatory filing for the disease or disorder being studied. If you have training, experience and clinical trial conduct knowledge, contact a sponsor and apply for a job.
Step 2

What does a Clinical Trial Manager do?

Clinical Trial Managers (CTM) have a large responsibility and the duties are delegated by the company's Project Manager. If the head of the project is a Vice President (VP), then the CTM's duties will be as designated by the VP. By regulations, these responsibilities should be described in writing. Typically, the CTM's main job is to make sure the clinical investigator's site have all the material they need to properly conduct the clinical trial. This could be done by interacting with the site personally or through a CRO. Overall, the CTM provides Case Report Forms, investigational product, adequate monitoring and all other sponsor support to the clinical investigator's site.
Step 3

What qualifications are required by law for me to be a CTM?

The FDA requirement for all persons participating in clinical research is that they be "scientifically qualified". The U.S. Title 21 Code of Federal Regulations (21 CFR) only describe the requirements for the clinical monitor (Clinical Research Associate or CRA), Clinical Investigator (also called principal investigator or PI), sponsor and Institutional Review Board (IRB). The CTM and other employees such as Quality Assurance, Data Management, Project Managers and other support personnel hired by the sponsor are not specifically identified in the regulations and therefore do not have a regulatory description of expected qualifications. However, each of these entities are expected to hire qualified people and they must therefore define "qualified" for their respective organization in written procedures.

The International Conference on Harmonization (ICH) for Industry is an established set of standard used worldwide for conducting clinical trials. The ICH guidelines require that “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective tasks." (ICH 2.8).
Step 4

What skill set should a CTM possess?

Two skills that I think are “must haves” for a CTM are 1)multi-tasking and 2) people skills. The majority of a CTM's time will be spent managing other people who are conducting or overseeing some aspect of the clinical trial. The CTM must be able to drive the process to make sure the job gets done. Some CTMs need to know about budgeting. When working for a small company, you will wear many hats so you will need to assist with getting an approved budget plan for the PI form a sponsor. Like the CRA, the CTM is a liaison between the clinical investigator site and the sponsor.

Therefore, once you can verify that you have experience, training and education in the job you want to apply for, send your resume to various companies' human resource department. Contact an executive search firm or headhunter and let them know you are looking for advancement or job opportunities.