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Clinical Study Manager Resume

Job Description:

A clinical study manager has to correspond with all client services and gather information on clinical study and ensure that all the objectives are achieved within the time schedule framed. He or she is also required to prepare the documents for all trials. He/she must analyze the documents and get the approval of concerned authorities like IRB. A clinical study manager has the responsibility to prepare all documents and recommend all necessary amendments as required. He/she also has to evaluate all protocols for the clinical study.

In order to complete all the studies within the specified time, the clinical study manager has to assist the hiring managers in drawing an effective recruitment plan. He/she has to go through all the information gathered by the investigators and clients and monitor all supplies and stock position. The receipts for the supplies made have to be kept safe and the inventories supplied for clinical trials are to be managed.

A clinical study manager must design all study connected documents, perform site investigation and follow the performance of the working committees. He or she has to ensure the distribution and maintenance of the documents for all the sites and monitor all study closure processes. By participating in all site qualification programs, he or she has to study the protocol deviations. Further, the clinical study manager should actively participate in the exit interviews along with the clients and participants.

Ashley E
728, Sunny Day Drive
Santa Ana
Phone: 714-800-3148

Job Objective:

I am seeking to get a clinical study manager position with a clear intention of making a positive contribution to the organization.

Qualifications Possessed:

  • I have good experience in clinical research and protocols.
  • I am highly proficient with the knowledge of FDA and ICH guidelines.
  • I am familiar with clinical practices.
  • I am proficient with computer applications and desktop office applications.
  • Have oral and written communication skills.
  • Have the capacity to analyze data, interpret them and summarize the reports in tabular form or in any required format.
  • I have the ability to maintain database in computer systems.

Professional Experience:

At present, I am working as a clinical study manager in ABC research, Inc. in Scranton, PA from January, 2006 to till date and my responsibilities are as follows.

  • I had studied contract agreements, schedules and budget reports and analyzed and interpreted them.
  • I had acted as consultant to several health and fitness organizations.
  • I am in charge of investigation on clinical trials and medical devices.
  • Have given training to the staff on clinical trials in respect of various investigational devices.
  • I am responsible for answering to the queries of the customers to their satisfaction.
  • I am responsible for developing clinical protocols and for the preparation of case report forms and manuals.
  • I am associated with the activities of clinical research organization and oversaw its functions.

Prior to the appointment stated above, I had worked as a clinical study manager in Creative Corporation in Pontiac, MI from October, 2001 to December, 2005 and was in charge of the following activities.

  • I had monitored the clinical trials as per the regulations laid down by the FDA.
  • I had analyzed and managed the investigator agreements and arranged for getting them approved.
  • I was responsible for resolving clinical and non-clinical issues with the cooperation of the employees.
  • I had attended all the study meetings and prepared the minutes of the meetings for references and record.
  • I was in charge of preparing and designing master files and documents.
  • I was responsible for the administration and distribution of payments to all the clinical projects.


I have a Bachelor's degree in Biomedical Engineering Technology from a University in Boston.


I am eager to produce the same at the time of interview.

It is a wrong belief that one need not send a resume to any employer and can get the desired job through business contacts. It may be true for a few people only and in fact, submission of resume is a great way to step into the doors of big companies and establishments for getting better jobs.

Therefore, you have to prepare an attractive and appealing clinical study manager resume if you desire to get that type of job. The importance of clinical study manager resume is that it shows how you have come up in life since you started working. This information will persuade the employers to allow you to continue your victory march by working in their establishments also.

Therefore, the details of clinical study manager resume should contain the information about how you performed in that capacity with your previous employers and the benefits contributed to them. This will allow the prospective employers to consider you as the best choice for their company and offer you appointment through interview.

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