Regional Clinical Trial Management Associate
New
B
BeOneClinical research
Remote (US)Full-TimeMiddle
Salary72,800 - 97,800 USD per year
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Job Details
- Experience
- 1 or more years of experience in clinical research within biotech, pharma or CRO industry.
- Required Skills
- SharePointMS Office
Requirements
- Have 1 or more years of clinical research experience within biotech, pharma, or CRO.
- Know clinical operations methodologies and operational aspects of clinical study processes.
- Be familiar with interpretation and implementation of regulations and ICH guidelines.
- Have experience or skills with MS Office, eTMF, and CTMS.
- Preferably hold a bachelor’s degree in a scientific or healthcare discipline; relevant clinical operations experience may be considered as an exception.
- A higher degree is preferred.
- Be available for limited travel if required.
Responsibilities
- Support regional and country study delivery and delegated clinical trial activities.
- Assist with feasibility assessment, study start-up, document generation and review, sample tracking, and participant enrollment.
- Support CRAs and study start-up specialists with CTMS updates, ISF binders, document collections, ICF customization, and eTMF maintenance.
- Create and maintain regional and country SharePoint folders, study distribution lists, and system records.
- Support regional and country team meetings, investigator meetings, and study-related communications.
- Maintain country- and site-level TMF records, including regular document review and quality control.
- Assist with regulatory submissions, monitoring visit preparation, clinical supplies, data cleaning, and site questions.
- Support operational risk identification, audit and inspection preparation, and quality improvements.
- Assist with regional vendor setup, study budget and purchase order administration, payment follow-up, and accruals.
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