Clinical Study Manager Resume

Posted in Resume Samples for Manager

Rita Walker
533 Providence Lane
Glendora, CA 91740

Job Objective Seeking a chance to work with a growing company through filling the Clinical Study Manager position and putting my experience to good use.

Highlights of Qualifications:

  • Admirable experience in clinical research and protocols
  • Exceptional knowledge of FDA and ICH guidelines
  • Deep knowledge of human anatomy
  • Ability to analyze data and summarize reports
  • Ability to prepare presentations
  • Excellent Microsoft Office skills
  • Good communication skills in both oral and written forms
  • Proficient to maintain computerized data systems

Professional Experience:

Clinical Study Manager
Innovation Works, Inc., Glendora, CA
October 2008 – Present

  • Performed investigation on clinical trials and medical devices.
  • Monitored clinical trials according to FDA requirements and regulations.
  • Evaluated investigational sites and maintained data integrity.
  • Managed investigator agreements and obtained required approvals.
  • Trained staff for clinical trials for various investigational devices.
  • Developed clinical protocols and prepared case report forms and manuals.
  • Prepared clinical data summaries for FDA regulations.
  • Assisted to resolve all data queries for customers.

Clinical Study Coordinator
ALung Technologies, Inc, Glendora, CA
August 2003 – September 2008

  • Organized and collect data for projects and prepared reports.
  • Evaluated patient records and included same in study.
  • Performed quality assurance tests and maintained inventory.
  • Maintained patient record and retrieved it as required.
  • Analyzed statistical data and reviewed available data for study.
  • Managed and analyzed data set within required timeframe.

Clinical Study Assistant
AGA Medical Corporation, Glendora, CA
May 1998 – July 2003

  • Coordinated with staff members and resolved clinical and non clinical issues.
  • Maintained inventory of all clinical supplies and provided purchase orders.
  • Developed and maintained documents and databases.
  • Participated in study meetings and prepared record of all minutes.
  • Designed and maintained master files and prepared documents.
  • Administered clinical project payments and distributed payments.


Bachelor’s Degree in Clinical Laboratory Science
Oglala Lakota College, Kyle, SD

Create your own professional looking resume for free using our resume builder!