Regional Clinical Trial Management Senior Associate
B
BeOneClinical research
Remote (US)Full-TimeSenior
Salary$83,800.00 - $113,800.00 annually
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Job Details
- Experience
- 2 or more years of experience in clinical research within biotech, pharma or CRO industry
- Required Skills
- MS Office
Requirements
- Have 2 or more years of clinical research experience in the biotech, pharmaceutical, or CRO industry.
- Bring knowledge of clinical operations methodologies and operational aspects of clinical study processes.
- Use MS Office, eTMF, and CTMS.
- Understand clinical research operations, including interpretation and implementation of regulations and ICH guidelines.
- Preferably hold a bachelor's degree, with a scientific or healthcare discipline preferred.
- A higher degree is preferred.
- Relevant clinical operations experience may be considered as an exception to the education requirement.
- Be available for limited travel, which might be required.
Responsibilities
- Support regional and country clinical trial conduct, including feasibility assessment, study start-up, document generation and review, sample tracking, and participant enrollment.
- Assist CRAs and Study Start-up Specialists with CTMS updates, ISF binder preparation, document collection, informed consent form customization, and eTMF maintenance.
- Set up and maintain regional and country study folders, distribution lists, systems, site records, and user access.
- Support study team and investigator meeting logistics, including agendas and minutes.
- Maintain country- and site-level TMFs, including regular document review and quality checks.
- Support study document review, local adaptation, data cleaning, follow-up of outstanding information, and clinical trial site questions.
- Help identify operational risks and support audit and inspection readiness, quality improvements, and development of regional tools and SOPs.
- Support regional vendor selection and management, study budgets, purchase orders, payments follow-up, and accrual activities.
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