Clinical Trial Management Associate
Behavioral Health Market Context
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Job Description
aintenance of the study's Trial Master File (TMF)
Required Qualifications
Minimum requirement of a BA/BS or equivalent degree
Clinical research experience, preferably in cell therapy and/or oncology
Knowledge of ICH/GCP guidelines and FDA requirements for INDs and NDAs
Experience with TMF maintenance and management
Ability to work independently and as part of a team
Required Qualifications
Minimum requirement of a BA/BS or equivalent degree
Clinical research experience, preferably in cell therapy and/or oncology
Knowledge of ICH/GCP guidelines and FDA requirements for INDs and NDAs
Experience with TMF maintenance and management
Ability to work independently and as part of a team
Qualifications
- •Minimum requirement of a BA/BS or equivalent degree
- •Clinical research experience, preferably in cell therapy and/or oncology
- •Knowledge of ICH/GCP guidelines and FDA requirements for INDs and NDAs
- •Experience with TMF maintenance and management
- •Ability to work independently and as part of a team
Benefits
Responsibilities
- •Support operational aspects of clinical trials, including study start-up, IRB submissions, enrollment, maintenance, and close-out
- •Conduct study tracking activities and assist with the development and oversight of essential clinical documents
- •Manage vendor performance and assist with the oversight and maintenance of the study's Trial Master File (TMF)