Clinical Trial Submissions Manager
- Job ID:
- Date:09/23/2008
- Location:Cincinnati
- State:Ohio
- Salary:Not Specified Why?
- Job Types:
-
CLINICAL AFFAIRS
Job Description
Medpace is a global contract research organization, headquartered in Cincinnati, Ohio, that manages the clinical trial process for pharmaceutical companies. We are currently seeking a Study Start-up Manager in the United Kingdom and in the United States. The individual chosen for this position will coordinate and oversee the study start-up activities at project start-up and throughout the study.
Job Duties:
Interacting with ethics committees and regulatory agencies;
Preparing and negotiating Informed Consent for the study sites;
Collecting site essential documentation; and
Reviewing pertinent regulations to develop proactive solutions to regulatory issues and challenges.
Qualifications:
Candidate must have a bachelor's degree;
3- 5 years of clinical trial experience (including study start-up experience) is required;
Knowledge of ICH guidelines and applicable local regulations regarding the conduct of clinical trials is expected;
This candidate should possess excellent written and oral skills; and
Advanced computer knowledge, especially with Microsoft® Office, is desired.
Travel: Minimal
Note: This position will initially be a home-based position until the office is established.
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